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Peptinote
Regulation

Peptide regulation tracker

The US status of every compound we cover, a dated timeline of FDA actions, and what each status means.

Medical review in progressLast reviewed 21 min read
On this page
  1. Status of every compound
  2. Recent changes
  3. What the categories mean
  4. How we keep this current
  5. Questions people ask
  6. Sources

This tracker shows the US regulatory status of every peptide and GLP-1 compound Peptinote covers, from FDA-approved medicines to unapproved “research” peptides, with a dated timeline of the FDA actions behind them. Each status links to the FDA pages, labels and records it is based on. It is information, not legal advice.

Status of every compound

Grouped from most to least regulated. Each row gives the status in plain language, the date we last verified it and its sources. Tap a name for the full compound page, including what the research shows.

Prescription medicines

FDA-approved medicines. Branded products follow their FDA label.

US regulatory status: prescription medicines
CompoundWhat the status means
DulaglutideUS status: FDA-approved

As of

Approved by the FDA (first in 2014) as Trulicity, made by Eli Lilly, to improve blood sugar in adults and children 10 and older with type 2 diabetes, and to lower the risk of heart attack, stroke and cardiovascular death in adults with type 2 diabetes and heart disease or several risk factors. It is not approved for weight management. The FDA’s shortage database lists the dulaglutide injection shortage as resolved, and as of October 15, 2026, dulaglutide was not on the FDA’s list of current drug shortages.

Sources212223

LiraglutideUS status: FDA-approved

As of

Approved by the FDA as Victoza (type 2 diabetes, and lowering heart risk in adults with type 2 diabetes and heart disease) and Saxenda (long-term weight management), both made by Novo Nordisk, with the first generics approved in December 2024 and August 2025. Liraglutide injection has been on the FDA drug shortage list since July 2023, compounded liraglutide is not FDA-approved, and in April 2026 the FDA proposed keeping liraglutide off the list of ingredients that outsourcing facilities may compound from.

Sources451617181920

OrforglipronUS status: FDA-approved

As of

The FDA approved orforglipron as Foundayo tablets (Eli Lilly) on April 1, 2026, for long-term weight management in adults with obesity, or with overweight and at least one weight-related condition, together with diet and exercise. Weight management is its only approved use: it has been studied in type 2 diabetes, but blood-sugar control is not on the label. Foundayo is the only FDA-approved orforglipron product; compounded or “research” versions are not FDA-approved and have not been reviewed for safety, effectiveness or quality.

Sources524252627

SemaglutideUS status: FDA-approved

As of

Novo Nordisk makes every FDA-approved semaglutide product. Ozempic injection is approved for adults with type 2 diabetes to improve blood sugar, to lower the risk of major cardiovascular events in those with established cardiovascular disease, and to lower the risk of kidney function decline, kidney failure and cardiovascular death in those with chronic kidney disease. Rybelsus and Ozempic tablets share one label: once-daily tablets for adults with type 2 diabetes, to improve blood sugar and to lower the risk of major cardiovascular events in those at high risk, and they are not interchangeable mg for mg. Wegovy injection is approved for long-term weight reduction in adults and children 12 and older with obesity, and in adults with overweight and a weight-related condition; to lower the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and obesity or overweight (since March 2024); and, under accelerated approval since August 2025, for noncirrhotic MASH with moderate to advanced liver fibrosis in adults. Its 7.2 mg dose, Wegovy HD, was approved on March 19, 2026, for weight reduction in adults only. Wegovy tablets, approved on December 22, 2025, are for adults, for weight reduction and heart risk reduction, and are not approved for MASH or for children. Compounded semaglutide is not FDA-approved: the FDA declared the shortage resolved on February 21, 2025, its grace periods for compounders ended in 2025, and on April 30, 2026 it proposed excluding semaglutide from the list outsourcing facilities may compound from (no final decision as of this date). Salt forms such as semaglutide sodium and acetate are different active ingredients from the approved drugs, and the FDA has sent warning letters to sellers of semaglutide labeled “for research purposes” or “not for human consumption”.

Sources3456789101112131415

SS-31US status: FDA-approved

As of

Elamipretide is FDA-approved only as Forzinity (Stealth BioTherapeutics), a ready-to-use injection granted accelerated approval on September 19, 2025 to improve muscle strength in people with Barth syndrome who weigh at least 30 kg; continued approval depends on a confirmatory trial. “SS-31” sold online as a research peptide is not Forzinity: in August 2026 the FDA told sellers their “SS-31 (Elamipretide)” products are unapproved new drugs, despite “research use only” labels.

Sources66667686970

TirzepatideUS status: FDA-approved

As of

Eli Lilly makes both FDA-approved products: Mounjaro, for type 2 diabetes (adults and children 10 and older) and to lower heart risk in high-risk adults with type 2 diabetes, and Zepbound, for long-term weight management and for sleep apnea with obesity in adults. Compounded tirzepatide is not FDA-approved: the FDA declared the shortage resolved on December 19, 2024, and in April 2026 proposed excluding it from the list outsourcing facilities may compound from. The FDA has also warned sellers of “research use only” tirzepatide.

Sources123456

Approved for one specific use

FDA-approved only for the use on the label. Products sold for anything else are unapproved.

US regulatory status: approved for one specific use
CompoundWhat the status means
PT-141US status: Approved for one use

As of

Bremelanotide is FDA-approved only as Vyleesi, a 1.75 mg single-dose autoinjector for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. The label says it is not indicated for men, for postmenopausal women or to enhance sexual performance. Nasal sprays and powder vials sold as “PT-141” are unapproved drugs, and in August 2026 the FDA sent warning letters to three websites selling them.

Sources6717273

TesamorelinUS status: Approved for one use

As of

FDA-approved as Egrifta WR and Egrifta SV (Theratechnologies) only to reduce excess abdominal fat in adults with HIV and lipodystrophy; the labels say it is not indicated for weight loss. The first Egrifta approval was on November 10, 2010. Tesamorelin sold online as a “research” peptide is an unapproved drug, and the FDA has sent warning letters to sellers. WADA prohibits it at all times.

Sources642434445

In clinical trials

Still being studied. Not FDA-approved for any use.

US regulatory status: in clinical trials
CompoundWhat the status means
CagrilintideUS status: Investigational

As of

Neither cagrilintide nor CagriSema (cagrilintide with semaglutide) is FDA-approved. Novo Nordisk submitted CagriSema for weight management in December 2025 and expected a decision by late 2026; no approval had been announced as of October 16, 2026. The FDA says cagrilintide cannot be used in compounding, and it has warned a website selling it as a “research” peptide.

Sources52732333435

MazdutideUS status: Investigational

As of

Not approved by the FDA for any use. China’s drug regulator (NMPA) approved mazdutide for chronic weight management (announced June 2025) and for type 2 diabetes (announced September 2025); it is sold there by Innovent Biologics under license from Eli Lilly. Lilly has published a US phase 2 trial, and we found no US phase 3 trial or FDA filing as of October 16, 2026. The FDA has warned companies selling mazdutide falsely labeled “for research purposes.”

Sources52735394041

RetatrutideUS status: Investigational

As of

Retatrutide is not approved by the FDA for any use and has no brand name. Eli Lilly published phase 3 trials in 2026, but no FDA filing or approval had been announced as of October 16, 2026. The FDA says retatrutide cannot be used in compounding, and it has warned telehealth companies, ingredient distributors and websites selling “research use only” retatrutide.

Sources562728293031

SurvodutideUS status: Investigational

As of

Survodutide is investigational and not approved by the FDA for any use. Boehringer Ingelheim has completed phase 3 obesity trials (SYNCHRONIZE-1 and -2, published in 2026) and is running phase 3 trials in MASH, a form of fatty liver disease; we found no FDA filing as of October 16, 2026. The FDA has warned companies selling survodutide falsely labeled “for research purposes” or “not for human consumption.”

Sources527363738

Not approved for human use

No FDA-approved product is available in the US.

US regulatory status: not approved for human use
CompoundWhat the status means
AOD-9604US status: Not approved

As of

AOD-9604 is not approved by the FDA for any use. The FDA previously placed it in Category 2 because of possible immune reactions and serious adverse events of unclear cause; the nomination was later withdrawn, and it is not on any list that allows pharmacy compounding (checked October 16, 2026). WADA bans it in sport at all times.

Sources454950

ARA-290US status: Not approved

As of

Cibinetide (ARA-290) is an investigational peptide that has never been approved by the FDA. None of its registered trials on ClinicalTrials.gov is active, and no phase 3 trial has been registered. The FDA lists it in Category 3 for pharmacy compounding: nominated without adequate support. It is not on the FDA’s Category 2 safety-risk page, and it was not on the agenda of the July 2026 compounding advisory committee meeting or the one planned before the end of February 2027.

Sources49505356596061

BPC-157US status: Not approved

As of

BPC-157 is not approved by the FDA for any use, and no country has approved a BPC-157 medicine. As of April 2026 the FDA lists it among substances whose nominations were withdrawn from its Category 2 safety-risk list; it is not in Category 1. In July 2026 an FDA advisory committee narrowly voted, against FDA staff advice, to recommend adding it to the 503A bulks list. That vote is not binding, and as of October 16, 2026 the FDA had not published a proposed or final rule. WADA bans it at all times (S0).

Sources454950525354

CJC-1295 / ipamorelinUS status: Not approved

As of

Neither peptide is approved by the FDA for any use, and no FDA-approved product contains either one, alone or blended. The FDA has cited serious adverse events with CJC-1295, including increased heart rate and a systemic vasodilatory reaction; the nomination to allow it in compounding was withdrawn, and it is on no list that permits compounding. Ipamorelin is in category 2 (significant safety risks) for outsourcing facilities (503B), and its 503A nomination was withdrawn. WADA prohibits both at all times.

Sources45474950

DihexaUS status: Not approved

As of

Dihexa is unapproved for human use in the US and has never been tested in a published human trial. The FDA moved dihexa acetate off its Category 2 list in April 2026 after the nomination was withdrawn, noting it has no human exposure data, and plans to discuss it with an advisory committee before the end of February 2027.

Sources4959

DSIPUS status: Not approved

As of

DSIP (emideltide) is not approved by the FDA for any use, and the FDA’s 2026 review found it registered in none of the countries it searched. In July 2026 an FDA advisory committee voted against adding it to the list of substances pharmacies may compound, citing weak evidence.

Sources49535479

EpitalonUS status: Not approved

As of

Epitalon is not approved by the FDA for any use; in April 2026 the FDA moved it off its Category 2 safety-risk list after the nomination was withdrawn. In July 2026 an FDA advisory committee voted, against FDA staff advice, to recommend adding it to the 503A bulks list; that vote is not binding, and as of October 16, 2026 the FDA had not published a proposed or final rule. The FDA found no approved epitalon product in the EU, the UK, Canada or Australia.

Sources4953547576

GHRP-6US status: Not approved

As of

Not approved by the FDA for any use. The FDA placed GHRP-6 in category 2 (significant safety risks) for outsourcing facilities on September 29, 2023, citing possible effects on cortisol and higher blood sugar; for pharmacy compounding (503A) it sits in category 3, nominated without adequate support. WADA prohibits it at all times.

Sources4547484950

IGF-1 LR3US status: Not approved

As of

IGF-1 LR3 is unapproved for human use in the US: no FDA-approved product contains it, and it is not on any FDA list that allows pharmacies or outsourcing facilities to compound it. The only FDA-approved IGF-1 medicine is mecasermin (Increlex), a copy of human IGF-1 for a rare growth disorder in children. WADA’s 2026 list prohibits IGF-1 and its analogues at all times.

Sources4547495051

KisspeptinUS status: Restricted

As of

Kisspeptin is not approved by the FDA for any use. Kisspeptin-10 has been in Category 2 of the FDA’s 503A compounding policy since September 29, 2023, because of possible immune reactions, impurities and limited safety data, and it remained there in the FDA’s May 14, 2026 update. It is not among the substances on the agenda of the FDA’s next compounding advisory committee meeting.

Sources49505964

KPVUS status: Not approved

As of

KPV is not approved by the FDA for any use. As of April 2026 its nomination had been withdrawn from the FDA’s Category 2 safety-risk list, which notes the FDA found no human exposure data by any route. In July 2026 an FDA advisory committee narrowly voted, against FDA staff advice, to recommend adding it to the 503A bulks list; the vote is not binding, and as of October 16, 2026 no rule had been published.

Sources49535474

LL-37US status: Not approved

As of

LL-37, a natural human antimicrobial peptide, is not approved by the FDA as a drug. As of April 2026 its nomination had been withdrawn from the FDA’s Category 2 safety-risk list, where the FDA noted animal findings of harm to male reproduction and possible tumor-promoting effects in some tissues. It is in no 503A or 503B nomination category. The FDA plans to discuss it with its compounding advisory committee before the end of February 2027.

Sources4749505659

Melanotan IIUS status: Not approved

As of

Melanotan II is not approved by the FDA for any use, and it is a different drug from afamelanotide (Scenesse), an implant approved for erythropoietic protoporphyria. The FDA’s compounding safety page cites case reports of melanoma, PRES, sympathomimetic toxidrome and priapism, and an FDA import alert covers melanotan products sold online. The FDA plans to discuss melanotan II with an advisory committee before the end of February 2027.

Sources49598081

MOTS-cUS status: Not approved

As of

MOTS-c is not approved by the FDA for any use. The FDA moved it off its Category 2 safety-risk list after the nomination was withdrawn, and it is not on any list that lets pharmacies compound it. In July 2026 an FDA advisory committee narrowly voted to recommend adding it to the 503A bulks list, against the FDA staff’s proposal; the vote is not binding, and as of October 16, 2026 the FDA had not published a proposed or final rule.

Sources4950535463

NAD+US status: Restricted

As of

No NAD+ injection is approved by the FDA. NAD is in Category 1 of the FDA’s interim 503A policy (list updated May 14, 2026), so state-licensed pharmacies may compound it under certain conditions while the FDA evaluates it; that is not an approval, and the FDA has warned compounders against making IV NAD+ from food-grade ingredients.

Sources506465

PinealonUS status: Not approved

As of

Pinealon is unapproved for human use in the US. It does not appear on the FDA’s compounding category lists, and it has not been reviewed by an FDA advisory committee.

Sources4950

SelankUS status: Not approved

As of

Selank is not approved by the FDA for any use. It is registered as an anxiolytic in Russia. In April 2026 the FDA moved selank acetate off its Category 2 safety-risk list after the nomination was withdrawn, without adding it to Category 1, and it has not been scheduled for advisory committee review.

Sources495077

SemaxUS status: Not approved

As of

Semax is not approved by the FDA for any use; in Russia it is a registered drug sold as 0.1% and 1% nasal drops. In July 2026 an FDA advisory committee voted, against FDA staff advice, to recommend adding semax to the 503A bulks list; that vote is not binding, and as of October 16, 2026 the FDA had not published a proposed or final rule.

Sources4953547678

SermorelinUS status: Discontinued

As of

No FDA-approved sermorelin product is marketed in the US. Geref (EMD Serono) was discontinued in 2008 and its approvals were withdrawn effective June 18, 2009; in 2013 the FDA determined it was not withdrawn for safety or effectiveness reasons. Sermorelin acetate is under evaluation (category 1) for outsourcing-facility compounding, which is not FDA approval, and WADA prohibits it at all times.

Sources45464748

TB-500US status: Not approved

As of

TB-500 is not approved by the FDA for any use and is not the same substance as thymosin beta-4. As of April 2026 its nomination had been withdrawn from the FDA’s Category 2 safety-risk list. In July 2026 an FDA advisory committee narrowly voted, against FDA staff advice, to recommend adding it to the 503A bulks list; the vote is not binding, and as of October 16, 2026 no rule had been published. WADA bans thymosin beta-4 and its derivatives, naming TB-500, at all times (S2.3).

Sources4549535455

Thymosin alpha-1US status: Not approved

As of

Thymosin alpha-1 (thymalfasin, sold abroad as Zadaxin) is not approved by the FDA. A 2009 review reported approvals in over 35 countries, mainly for hepatitis B and C. In the US it is on the FDA’s list of Category 2 nominations that were withdrawn, which cites a significant risk of immune reactions, and it sits in Category 3 (nominated without adequate support) for outsourcing facilities. It is not scheduled for advisory committee review.

Sources47495356575859

Cosmetic ingredients

Sold mainly in skin and hair products. No drug form is FDA-approved.

US regulatory status: cosmetic ingredients
CompoundWhat the status means
GHK-CuUS status: Cosmetic

As of

GHK-Cu is sold mainly in cosmetics, which don’t need FDA approval, and no GHK-Cu drug is FDA-approved. Injectable GHK-Cu is not on any list that allows pharmacy compounding, and the FDA has flagged it for possible immune reactions. Non-injectable GHK-Cu was put back in Category 1 in May 2026, ahead of an FDA advisory committee review planned before the end of February 2027.

Sources49505962

Recent changes

The FDA actions and other events that shaped these statuses, newest first. We add an event only when we can link to the record of it.

  1. Enforcement

    Warning letter to an online seller of “research” peptides

    The FDA told a website selling semaglutide, tirzepatide, retatrutide, tesamorelin, PT-141 and other peptides, together with bacteriostatic water, that these products are unapproved new drugs. The FDA noted that injectable products bypass some of the body’s key defenses against toxins and microorganisms.

    Source6

  2. Compounding

    Advisory committee votes on seven peptides

    Over two days (July 23 and 24), the FDA’s Pharmacy Compounding Advisory Committee voted to recommend adding BPC-157, KPV, TB-500, MOTS-c, epitalon and semax to the list of substances pharmacies may compound, and rejected emideltide. FDA staff reviewers had advised against every one. The vote is non-binding: the FDA must still propose and finalize a rule.

    Sources5354

  3. Compounding

    Non-injectable GHK-Cu returns to Category 1

    After a nominator clarified that it had withdrawn only the injectable route, the FDA put GHK-Cu (except for injectable routes) back in Category 1 of its interim 503A policy. The FDA plans to discuss GHK-Cu, melanotan II, LL-37, dihexa and PEG-MGF with its advisory committee before the end of February 2027.

    Sources5059

  4. Compounding

    FDA proposes to keep GLP-1s off the 503B bulks list

    The FDA proposed excluding semaglutide, tirzepatide and liraglutide from the list of bulk ingredients that outsourcing facilities may compound from, finding no clinical need. Comments closed on June 29, 2026, and the FDA said it would consider them before a final determination.

    Source4

  5. Compounding

    Popular peptides move to “nominated but withdrawn”

    The FDA’s safety-risk page, updated April 22, 2026, lists BPC-157, TB-500, CJC-1295, AOD-9604, MOTS-c, KPV, epitalon, melanotan II, injectable GHK-Cu and others as previously in Category 2 but withdrawn by the people who nominated them. Withdrawal is not a safety finding: the FDA’s safety concerns are still listed for each one.

    Sources4950

  6. Approval

    First oral non-peptide GLP-1 approved for weight

    The FDA approved Foundayo (orforglipron), a once-daily tablet for long-term weight management in adults with obesity, or overweight with a weight-related condition. The same day, the FDA restated the conditions compounders must meet for GLP-1 drugs.

    Sources32427

  7. Enforcement

    Warning letter over “Research Use Only” GLP-1s

    The FDA told a website selling retatrutide and tirzepatide labeled “Research Use Only” that the labels did not change what the products were: the site’s own claims showed they were intended for human use, which makes them unapproved new drugs.

    Source31

  8. Anti-doping

    WADA’s 2026 Prohibited List takes effect

    The 2026 List names BPC-157 among non-approved substances and covers TB-500, CJC-1295, ipamorelin, sermorelin, tesamorelin, AOD-9604 and, for male athletes, kisspeptin among peptide hormones and growth factors. Both classes are prohibited at all times, in and out of competition.

    Source45

  9. In review

    CagriSema submitted to the FDA

    Novo Nordisk submitted a new drug application for CagriSema, a weekly injection combining cagrilintide with semaglutide. Submission is not approval; we found no FDA approval in the agency’s list of 2026 novel drug approvals.

    Sources2732

  10. Shortage

    Last semaglutide compounding grace period ends

    After the semaglutide shortage ended, the FDA’s enforcement grace period for state-licensed pharmacies ended once a court denied a preliminary injunction on April 24, 2025, and the period for outsourcing facilities ran until May 22, 2025.

    Source3

  11. Shortage

    Tirzepatide compounding grace periods end

    The grace period for state-licensed pharmacies ended after a court denied a preliminary injunction on March 5, 2025. The period for outsourcing facilities ended on March 19, 2025.

    Source3

  12. Shortage

    Semaglutide shortage declared resolved

    The FDA determined that the shortage of semaglutide injection products, ongoing since 2022, was resolved, and set out time-limited grace periods for compounders.

    Source3

  13. Shortage

    Tirzepatide shortage declared resolved

    After re-evaluating its October 2024 decision, the FDA again determined that the tirzepatide injection shortage was resolved. When a shortage ends, the FDA generally treats the drug as commercially available, which limits compounded copies.

    Source3

  14. Enforcement

    Warning letter over “research chemical” GLP-1s

    The FDA warned a website selling semaglutide, retatrutide, cagrilintide, tirzepatide and mazdutide labeled “research use only” that, based on its own marketing claims, the products were unapproved new drugs intended for people.

    Source35

  15. Compounding

    Several peptides added to Category 2

    The FDA added peptides including kisspeptin-10 (for pharmacy compounding) and ipamorelin, GHRP-2 and GHRP-6 (for outsourcing facilities) to Category 2, its list of bulk substances that may present significant safety risks, citing possible immune reactions and peptide-related impurities.

    Source49

What the categories mean

FDA-approved prescription drug. The FDA has reviewed the evidence for safety, effectiveness and manufacturing quality, and the product has an official label that sets out its uses, doses and risks.

Approved for a different use. An approved product exists, but only for a specific condition or form. Tesamorelin, for example, is approved only for abdominal fat in adults with HIV and lipodystrophy. The same substance sold for anything else is unapproved.

Investigational. In clinical trials, with no approval for any use. The FDA states that retatrutide and cagrilintide cannot be used in compounding (FDA).

Not approved for human use in the US. No approved product exists. When we are unsure, we use this label.

Discontinued. A product was once approved, but none is marketed now.

Compounding restricted. The FDA has placed the substance in Category 2, its list of bulk substances that may present significant safety risks in compounding.

Cosmetic ingredient. Sold mainly in skin and hair products, which don’t need FDA approval. A product claiming to change how the body works is a drug (FDA).

Compounding terms

  • 503A pharmacies are state-licensed pharmacies and physicians compounding for individual patients with a prescription. They may use a bulk ingredient only if it has a USP monograph, is part of an FDA-approved drug, or is on the 503A bulks list (FDA).
  • 503B outsourcing facilities are a separate class of compounders. They generally may use a bulk ingredient only if it is on the 503B bulks list or the drug is on the FDA’s shortage list (FDA).
  • Categories 1, 2 and 3 are the FDA’s interim policy while it evaluates nominated ingredients. Category 1 substances are under evaluation and may be compounded under conditions; Category 2 substances raise significant safety risks; Category 3 substances were nominated without enough supporting information (FDA).
  • Nominated but withdrawn means a substance was in Category 2 until the people who nominated it withdrew the nomination. It is then outside the categories altogether, not cleared: the FDA still lists its safety concerns (FDA).
  • Advisory committee votes are non-binding recommendations (FDA). The FDA adds substances to the 503A list through notice-and-comment rulemaking (FDA).
  • Shortage resolved means the FDA considers an approved drug commercially available again, which limits compounded copies of it (FDA).

“Research use only” is not a status

A “research use only” or “not for human consumption” label doesn’t change how the FDA sees a product sold for people. In its warning letters, the FDA treats such products as unapproved new drugs when the seller’s own claims show they are meant for human use (FDA warning letter, 2026).

How we keep this current

Every status and event links to a primary record: FDA labels on DailyMed, FDA web pages and warning letters, advisory committee materials, or the WADA Prohibited List. Where the FDA has not published its own summary, as with the July 2026 advisory committee votes, we cite reporting and say so. Each row shows the date we last verified it. Our editorial policy explains how we source and correct, and the compound directory has the evidence for each one.

Questions people ask

Which peptides are FDA-approved?

Among the compounds we cover, semaglutide (Ozempic, Wegovy, Rybelsus) and tirzepatide (Mounjaro, Zepbound) are FDA-approved medicines. Tesamorelin and bremelanotide (PT-141) are approved for one specific use each. More than 80 peptide drugs have reached the market worldwide since insulin (Muttenthaler et al., 2021), but most peptides sold online are not approved.

What does Category 2 mean?

It is the FDA’s list of bulk substances that may present significant safety risks in compounding, published while the agency evaluates them. A pharmacy compounding with a Category 2 substance falls outside the FDA’s interim policy, so the FDA may take action under its general enforcement policies.

Did the FDA approve BPC-157 in 2026?

No. In July 2026, an FDA advisory committee voted to recommend adding BPC-157 to the list of substances pharmacies may compound from. That is not drug approval, the vote is non-binding, and the FDA must publish a proposed and a final rule before anything changes.

Sources

  1. MOUNJARO (tirzepatide) injection, prescribing informationDailyMed, U.S. National Library of Medicine, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  2. ZEPBOUND (tirzepatide) injection, prescribing informationDailyMed, U.S. National Library of Medicine, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  3. FDA clarifies policies for compounders as national GLP-1 supply begins to stabilizeU.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  4. FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks ListU.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  5. FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight LossU.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  6. Warning letter: TXP Innovations LLC dba Tex Peptides (MARCS-CMS 735067)U.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  7. OZEMPIC (semaglutide) injection, prescribing informationDailyMed, U.S. National Library of Medicine, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  8. RYBELSUS and OZEMPIC (semaglutide) tablets, prescribing informationDailyMed, U.S. National Library of Medicine, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  9. WEGOVY (semaglutide) injection and tablets, prescribing informationDailyMed, U.S. National Library of Medicine, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  10. Drugs@FDA: NDA 218316 (WEGOVY tablets), approval historyU.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  11. Drugs@FDA: NDA 213051 (RYBELSUS and OZEMPIC tablets), approval historyU.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  12. FDA Approves Fourth Product Under National Priority Voucher Program, Higher Dose SemaglutideU.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  13. FDA Approves Treatment for Serious Liver Disease Known as ‘MASH’U.S. Food and Drug Administration, 2025 · Accessed Oct 16, 2026 (opens in a new tab)
  14. FDA Approves First Treatment to Reduce Risk of Serious Heart Problems Specifically in Adults with Obesity or OverweightU.S. Food and Drug Administration, 2024 · Accessed Oct 16, 2026 (opens in a new tab)
  15. Compounding and the FDA: Questions and AnswersU.S. Food and Drug Administration, 2025 · Accessed Oct 16, 2026 (opens in a new tab)
  16. VICTOZA (liraglutide) injection, prescribing informationDailyMed, U.S. National Library of Medicine, 2025 · Accessed Oct 16, 2026 (opens in a new tab)
  17. SAXENDA (liraglutide) injection, prescribing informationDailyMed, U.S. National Library of Medicine, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  18. FDA Approves First Generic of Once-Daily GLP-1 Injection to Lower Blood Sugar in Patients with Type 2 DiabetesU.S. Food and Drug Administration, 2024 · Accessed Oct 16, 2026 (opens in a new tab)
  19. Performance Report to Congress: Generic Drug User Fee Amendments, FY 2025U.S. Food and Drug Administration, 2025 · Accessed Oct 16, 2026 (opens in a new tab)
  20. FDA Drug Shortages: Liraglutide InjectionU.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  21. TRULICITY (dulaglutide) injection, prescribing informationDailyMed, U.S. National Library of Medicine, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  22. FDA Drug Shortages: Dulaglutide InjectionU.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  23. FDA Drug Shortages: Current and Resolved Drug Shortages and Discontinuations Reported to FDAU.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  24. FOUNDAYO (orforglipron) tablets, prescribing informationDailyMed, U.S. National Library of Medicine, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  25. Drugs@FDA: NDA 220934, FOUNDAYOU.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  26. FDA Approves First New Molecular Entity Under National Priority Voucher ProgramU.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  27. Novel Drug Approvals for 2026U.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  28. Retatrutide, a Triple Hormone Receptor Agonist, for Treatment of ObesityN Engl J Med, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  29. Retatrutide in adults with obesity and type 2 diabetes (TRIUMPH-2): a double-blind, parallel-group, randomised, placebo-controlled, phase 3 trialLancet, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  30. A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight (TRIUMPH-1), NCT05929066ClinicalTrials.gov, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  31. Warning letter: Gram Peptides (MARCS-CMS 721806)U.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  32. Novo Nordisk files for FDA approval of CagriSema, the first once-weekly combination of GLP-1 and amylin analogues for weight managementNovo Nordisk, 2025 · Accessed Oct 16, 2026 (opens in a new tab)
  33. CagriSema demonstrated 23% weight loss in an open-label head-to-head REDEFINE 4 trial in people with obesity; the primary endpoint was not achievedNovo Nordisk, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  34. A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight (REDEFINE 1), NCT05567796ClinicalTrials.gov, 2025 · Accessed Oct 16, 2026 (opens in a new tab)
  35. Warning letter: Summit Research Peptides (MARCS-CMS 695607)U.S. Food and Drug Administration, 2024 · Accessed Oct 16, 2026 (opens in a new tab)
  36. Survodutide Once Weekly for the Treatment of Adults with ObesityN Engl J Med, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  37. Survodutide Once Weekly in Adults with Obesity and Type 2 DiabetesN Engl J Med, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  38. LIVERAGE: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Scarring, NCT06632444ClinicalTrials.gov, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  39. Weight loss medicine Mazdutide approved for commercialization in ChinaShanghai Municipal People's Government, 2025 · Accessed Oct 16, 2026 (opens in a new tab)
  40. Innovent Announces Mazdutide Received Approval from China’s NMPA for Glycemic Control in Adults with Type 2 DiabetesInnovent Biologics (press release via BioSpace), 2025 · Accessed Oct 16, 2026 (opens in a new tab)
  41. Efficacy and safety of mazdutide in adults with obesity or overweight: a US-based, multicentre, phase 2, randomised, placebo-controlled clinical trialLancet Diabetes Endocrinol, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  42. EGRIFTA WR (tesamorelin) for injection, prescribing informationDailyMed, U.S. National Library of Medicine, 2025 · Accessed Oct 16, 2026 (opens in a new tab)
  43. EGRIFTA SV (tesamorelin) for injection, prescribing informationDailyMed, U.S. National Library of Medicine, 2024 · Accessed Oct 16, 2026 (opens in a new tab)
  44. Drugs@FDA: EGRIFTA (BLA 022505)U.S. Food and Drug Administration · Accessed Oct 16, 2026 (opens in a new tab)
  45. World Anti-Doping Code International Standard: Prohibited List 2026World Anti-Doping Agency, 2025 · Accessed Oct 16, 2026 (opens in a new tab)
  46. Determination That GEREF (Sermorelin Acetate) Injection, 0.5 Milligrams Base/Vial and 1.0 Milligrams Base/Vial, and GEREF (Sermorelin Acetate) Injection, 0.05 Milligrams Base/Amp, Were Not Withdrawn From Sale for Reasons of Safety or EffectivenessFederal Register (U.S. Food and Drug Administration), 2013 · Accessed Oct 16, 2026 (opens in a new tab)
  47. Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic ActU.S. Food and Drug Administration, 2025 · Accessed Oct 16, 2026 (opens in a new tab)
  48. Bulk Drug Substances Used in Compounding Under Section 503B of the FD&C ActU.S. Food and Drug Administration, 2025 · Accessed Oct 16, 2026 (opens in a new tab)
  49. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety RisksU.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  50. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act (updated May 14, 2026)U.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  51. INCRELEX (mecasermin) injection, prescribing informationDailyMed, U.S. National Library of Medicine, 2025 · Accessed Oct 16, 2026 (opens in a new tab)
  52. FDA Briefing Document for BPC-157-Related Bulk Drug Substances (PCAC, July 23-24, 2026)U.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  53. July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory CommitteeU.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  54. FDA advisers narrowly vote to add 6 peptides to a drug compounding list. What’s next?ABC News, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  55. FDA Briefing Document for TB-500-Related Bulk Drug Substances (PCAC, July 23-24, 2026)U.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  56. Drugs@FDA: FDA-Approved DrugsU.S. Food and Drug Administration · Accessed Oct 16, 2026 (opens in a new tab)
  57. From lab to bedside: emerging clinical applications of thymosin alpha 1Expert Opin Biol Ther, 2009 · Accessed Oct 16, 2026 (opens in a new tab)
  58. First Line Bio-immunotherapy With Thymosin Alpha 1 in Patients With Sensitizing EGFR Mutation, NCT02906163ClinicalTrials.gov, 2016 · Accessed Oct 16, 2026 (opens in a new tab)
  59. Meeting of the Pharmacy Compounding Advisory Committee (to be held before the end of February 2027)U.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  60. Cibinetide Improves Corneal Nerve Fiber Abundance in Patients With Sarcoidosis-Associated Small Nerve Fiber Loss and Neuropathic PainInvest Ophthalmol Vis Sci, 2017 · Accessed Oct 16, 2026 (opens in a new tab)
  61. ARA 290 phase 2 trial in sarcoidosis-associated small nerve fiber loss, NCT02039687ClinicalTrials.gov · Accessed Oct 16, 2026 (opens in a new tab)
  62. Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)U.S. Food and Drug Administration, 2024 · Accessed Oct 16, 2026 (opens in a new tab)
  63. FDA Briefing Document for MOTS-c-Related Bulk Drug Substances (PCAC, July 23-24, 2026)U.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  64. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C ActU.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  65. FDA reminds compounders to use ingredients suitable for sterile compoundingU.S. Food and Drug Administration, 2024 · Accessed Oct 16, 2026 (opens in a new tab)
  66. FORZINITY (elamipretide) injection, for subcutaneous use, prescribing informationU.S. Food and Drug Administration, 2025 · Accessed Oct 16, 2026 (opens in a new tab)
  67. Drugs@FDA: NDA 215244, FORZINITYU.S. Food and Drug Administration, 2025 · Accessed Oct 16, 2026 (opens in a new tab)
  68. NDA 215244 accelerated approval letter (Forzinity), September 19, 2025U.S. Food and Drug Administration, 2025 · Accessed Oct 16, 2026 (opens in a new tab)
  69. FDA grants accelerated approval for first treatment for Barth syndromeU.S. Food and Drug Administration, 2025 · Accessed Oct 16, 2026 (opens in a new tab)
  70. Warning letter: Royal Peptides LLC (MARCS-CMS 734884)U.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  71. VYLEESI (bremelanotide) injection, prescribing informationDailyMed, U.S. National Library of Medicine, 2025 · Accessed Oct 16, 2026 (opens in a new tab)
  72. Warning letter: Peak Performance Peptides (MARCS-CMS 735127)U.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  73. Warning letter: NuScience Peptides LLC (MARCS-CMS 733652)U.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  74. FDA Briefing Document for KPV-Related Bulk Drug Substances (PCAC, July 23-24, 2026)U.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  75. FDA Briefing Document for Epitalon-Related Bulk Drug Substances (PCAC, July 23-24, 2026)U.S. Food and Drug Administration, 2026 · Accessed Oct 15, 2026 (opens in a new tab)
  76. Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances ListFederal Register (U.S. Food and Drug Administration), 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  77. Development of Peptide Biopharmaceuticals in RussiaPharmaceutics, 2022 · Accessed Oct 16, 2026 (opens in a new tab)
  78. FDA Briefing Document for Semax-Related Bulk Drug Substances (PCAC, July 23-24, 2026)U.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  79. FDA Briefing Document for Emideltide-Related Bulk Drug Substances (PCAC, July 23-24, 2026)U.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  80. SCENESSE (afamelanotide) implant, prescribing informationDailyMed, U.S. National Library of Medicine, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  81. Import Alert 66-41: Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.U.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
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