Statistics, Sourced

FDA-Approved Peptides: 2026 List and Statistics

Published by Peptara Labs · Updated November 5, 2026 · How we research and check our pages

The short answer

FDA-approved peptides are peptide drugs that passed FDA review for the uses on their labels, and Peptara Labs (peptaralabs.io) lists the main ones here, each with its FDA record. The list gives each drug's class and approval year. Counts differ by source, so every count below says what it counts and who counted.

Each figure has its source in small italic text right under it, and the full list of sources is at the foot of the page. We recheck the figures against FDA records every month. This page is education only: it names drugs by their generic names and does not say who should use any of them.

What does FDA-approved mean for a peptide?

It means FDA reviewed one company’s product and found that its benefits outweigh its risks for the uses on its label.

One product, one label. Each approval belongs to an application with its own number in Drugs@FDA, such as NDA 021773 for exenatide, and to the uses on that label. FDA says that when an approved drug is used for another purpose, FDA has not found it safe and effective for that use.
Compounded is not approved. FDA states that compounded drugs are not FDA-approved, so the agency does not check their safety, effectiveness or quality before they are sold.
Research use only is not a status. Drugs@FDA lists only FDA-approved drugs. A vial sold for research is not the approved product, even when the molecule has the same name. A research label does not create an approval. Whether a vial may be bought or brought into a country is a legal question, covered on are peptides legal.
Supplements are not approved either. Dietary supplements do not need FDA approval to be sold, so a peptide sold as a supplement has none.

For the one-line version, see FDA-approved in the peptide glossary.

Sources: FDA, Development and Approval Process: Drugs; FDA, Understanding Unapproved Use of Approved Drugs “Off Label”; FDA, Compounding and the FDA: Questions and Answers; FDA, Drugs@FDA Frequently Asked Questions.

How many peptide drugs has the FDA approved?

There is no single number. One academic database counts 51 peptide ingredients with FDA approvals, and a 2021 review counted more than 80 peptide drugs that have reached the market since insulin.

Sources: CDEK, FDA Approvals: Peptide, read November 5, 2026; Muttenthaler and colleagues, Nature Reviews Drug Discovery, 2021.

Figures on FDA-approved peptide drugs, each with what it measures and its source
Figure	What it means
40 amino acids	FDA’s line between a peptide and a protein. FDA calls a chain of 40 or fewer amino acids a peptide. Above 40, its rules treat the chain as a protein, which is licensed as a biologic.
FDA, Deemed to be a License Provision of the BPCI Act; 21 CFR 600.3(h)(6).
51	Active ingredients in the peptide class of CDEK, an academic drug database from Purdue University and Stony Brook University. It is built from Drugs@FDA and the Purple Book, and it leaves out older approvals.
CDEK, FDA Approvals: Peptide, read November 5, 2026.
6	Brand (innovator) approvals for oxytocin in CDEK, the most of any peptide there. Semaglutide has 5, and teriparatide, exenatide and octreotide have 4 each.
CDEK, top innovator ingredients, read November 5, 2026.
23	Generic approvals for octreotide in CDEK, the most of any peptide there. Eptifibatide is next with 15.
CDEK, top generic ingredients, read November 5, 2026.
More than 80	Peptide drugs that had reached the market since insulin was introduced, in a 2021 review. The review starts its count with insulin, which FDA treats as a protein product.
Muttenthaler and colleagues, Nature Reviews Drug Discovery, 2021, PMID 33536635; FDA, Deemed to be a License Provision.
1 of 46	Peptides among the 46 novel drugs FDA approved in 2025, in a yearly review of peptide and oligonucleotide approvals.
AlShaer and colleagues, Pharmaceuticals, 2026, PMID 41754785; FDA, Novel Drug Approvals for 2025.

Why the counts differ

The line at 40 amino acids moves drugs from one group to another. Tesamorelin and lixisenatide each have 44 amino acids on their labels. Both were approved as drugs, and on March 23, 2020 their approvals became biologics licenses under the Biologics Price Competition and Innovation Act. A count that follows the FDA line leaves them out, while a count by drug class keeps them. Databases also differ in how far back they reach.

Sources: FDA, List of Approved NDAs Deemed to be BLAs on March 23, 2020; tesamorelin label; lixisenatide label; CDEK.

Which peptide drugs has the FDA approved?

The tables below sort FDA-approved peptide drugs by class. Each row gives the year of the earliest dated approval in Drugs@FDA, from glucagon in 1960 to rusfertide in 2026.

Sources: Drugs@FDA, NDA 012122 and NDA 220605.

A drug made the list if it has an approved application in Drugs@FDA. Its FDA label, an NLM record or a journal also had to describe it as a peptide or a short chain of amino acids. The list covers the main peptide classes and is not a full count. Insulin is left out, because FDA treats insulin as a protein.

A year shows when FDA first approved the ingredient. It does not mean a product is sold today. Drugs@FDA shows each product's current marketing status, and some, such as sermorelin and abarelix, are listed as discontinued.

Sources: FDA, Drugs@FDA Frequently Asked Questions; FDA, Deemed to be a License Provision; Drugs@FDA, NDA 019863 and NDA 021320.

FDA-approved peptide drugs by drug class

GLP-1 and GIP receptor agonists

GLP-1 and GIP receptor agonists: earliest dated FDA approval and the Drugs@FDA record for each
Peptide	Earliest dated approval
Exenatide	2005
Drugs@FDA, NDA 021773, Byetta: approved April 28, 2005.
Liraglutide	2010
Drugs@FDA, NDA 022341, Victoza: approved January 25, 2010.
Lixisenatide	2016
Drugs@FDA, BLA 208471, Adlyxin: approved July 27, 2016 as a drug application, then deemed a biologics license on March 23, 2020. Label: 44 amino acids.
Semaglutide	2017
Drugs@FDA, NDA 209637, Ozempic: approved December 5, 2017.
Tirzepatide	2022
Drugs@FDA, NDA 215866, Mounjaro: approved May 13, 2022.

Glucagon, amylin and their analogs

Glucagon, amylin and their analogs: earliest dated FDA approval and the Drugs@FDA record for each
Peptide	Earliest dated approval
Glucagon	1960
Drugs@FDA, NDA 012122, Glucagon: approved November 14, 1960.
Pramlintide	2005
Drugs@FDA, NDA 021332, Symlin: approved March 16, 2005.
Dasiglucagon	2021
Drugs@FDA, NDA 214231, Zegalogue: approved March 22, 2021.

Growth hormone releasing hormone analogs

Growth hormone releasing hormone analogs: earliest dated FDA approval and the Drugs@FDA record for each
Peptide	Earliest dated approval
Sermorelin	1990
Drugs@FDA, NDA 019863, Geref: approved December 28, 1990.
Tesamorelin	2010
Drugs@FDA, BLA 022505, Egrifta: approved November 10, 2010 as a drug application, then deemed a biologics license on March 23, 2020. Label: 44 amino acids.

Natriuretic peptides

Natriuretic peptides: earliest dated FDA approval and the Drugs@FDA record for each
Peptide	Earliest dated approval
Nesiritide	2001
Drugs@FDA, NDA 020920, Natrecor: approved August 10, 2001.
Vosoritide	2021
Drugs@FDA, NDA 214938, Voxzogo: approved November 19, 2021.
Navepegritide	2026
Drugs@FDA, NDA 219164, Yuviwel: approved February 27, 2026.

Somatostatin analogs

Somatostatin analogs: earliest dated FDA approval and the Drugs@FDA record for each
Peptide	Earliest dated approval
Octreotide	1988
Drugs@FDA, NDA 019667, Sandostatin: approved October 21, 1988.
Lanreotide	2007
Drugs@FDA, NDA 022074, Somatuline Depot: approved August 30, 2007.
Pasireotide	2012
Drugs@FDA, NDA 200677, Signifor: approved December 14, 2012.

GnRH agonists and antagonists

GnRH agonists and antagonists: earliest dated FDA approval and the Drugs@FDA record for each
Peptide	Earliest dated approval
Leuprolide	1985
Drugs@FDA, NDA 019010, Lupron: approved April 9, 1985.
Goserelin	1989
Drugs@FDA, NDA 019726, Zoladex: approved December 29, 1989.
Nafarelin	1990
Drugs@FDA, NDA 019886, Synarel: approved February 13, 1990.
Histrelin	1991
Drugs@FDA, NDA 019836, Supprelin: approved December 24, 1991.
Ganirelix	1999
Drugs@FDA, NDA 021057, Ganirelix Acetate: approved July 29, 1999.
Triptorelin	2000
Drugs@FDA, NDA 020715, Trelstar: approved June 15, 2000.
Cetrorelix	2000
Drugs@FDA, NDA 021197, Cetrotide: approved August 11, 2000.
Abarelix	2003
Drugs@FDA, NDA 021320, Plenaxis: approved November 25, 2003.
Degarelix	2008
Drugs@FDA, NDA 022201, Firmagon: approved December 24, 2008.

Oxytocin, vasopressin and their analogs

Oxytocin, vasopressin and their analogs: earliest dated FDA approval and the Drugs@FDA record for each
Peptide	Earliest dated approval
Desmopressin	1978
Drugs@FDA, NDA 017922, DDAVP: approved February 21, 1978.
Oxytocin	1980
Drugs@FDA, NDA 018245, Syntocinon: approved April 17, 1980. An older application, NDA 012285, Syntocinon, has no date in Drugs@FDA.
Vasopressin	2014
Drugs@FDA, NDA 204485, Vasostrict: approved April 17, 2014. An older application, NDA 003402, Pitressin Tannate, has no date in Drugs@FDA.
Terlipressin	2022
Drugs@FDA, NDA 022231, Terlivaz: approved September 14, 2022.

Calcitonin and parathyroid hormone peptides

Calcitonin and parathyroid hormone peptides: earliest dated FDA approval and the Drugs@FDA record for each
Peptide	Earliest dated approval
Calcitonin salmon	1978
Drugs@FDA, NDA 017769, Calcimar: approved April 17, 1978. An older application, NDA 017497, Calcimar, has no date in Drugs@FDA.
Teriparatide	2002
Drugs@FDA, NDA 021318, Forteo: approved November 26, 2002. An older application, NDA 019498, Parathar, has no date in Drugs@FDA.
Abaloparatide	2017
Drugs@FDA, NDA 208743, Tymlos: approved April 28, 2017.
Palopegteriparatide	2024
Drugs@FDA, NDA 216490, Yorvipath: approved August 9, 2024.

Melanocortin receptor agonists

Melanocortin receptor agonists: earliest dated FDA approval and the Drugs@FDA record for each
Peptide	Earliest dated approval
Bremelanotide	2019
Drugs@FDA, NDA 210557, Vyleesi: approved June 21, 2019.
Afamelanotide	2019
Drugs@FDA, NDA 210797, Scenesse: approved October 8, 2019.
Setmelanotide	2020
Drugs@FDA, NDA 213793, Imcivree: approved November 25, 2020.

Gut peptides

Gut peptides: earliest dated FDA approval and the Drugs@FDA record for each
Peptide	Earliest dated approval
Linaclotide	2012
Drugs@FDA, NDA 202811, Linzess: approved August 30, 2012.
Teduglutide	2012
Drugs@FDA, NDA 203441, Gattex: approved December 21, 2012.
Plecanatide	2017
Drugs@FDA, NDA 208745, Trulance: approved January 19, 2017.

Antiplatelet and anticoagulant peptides

Antiplatelet and anticoagulant peptides: earliest dated FDA approval and the Drugs@FDA record for each
Peptide	Earliest dated approval
Eptifibatide	1998
Drugs@FDA, NDA 020718, Integrilin: approved May 18, 1998.
Bivalirudin	2000
Drugs@FDA, NDA 020873, Angiomax: approved December 15, 2000.

Anti-infective peptides

Anti-infective peptides: earliest dated FDA approval and the Drugs@FDA record for each
Peptide	Earliest dated approval
Enfuvirtide	2003
Drugs@FDA, NDA 021481, Fuzeon: approved March 13, 2003.
Daptomycin	2003
Drugs@FDA, NDA 021572, Cubicin: approved September 12, 2003.

Complement inhibitors

Complement inhibitors: earliest dated FDA approval and the Drugs@FDA record for each
Peptide	Earliest dated approval
Pegcetacoplan	2021
Drugs@FDA, NDA 215014, Empaveli: approved May 14, 2021.
Zilucoplan	2023
Drugs@FDA, NDA 216834, Zilbrysq: approved October 17, 2023.

Nervous system peptides

Nervous system peptides: earliest dated FDA approval and the Drugs@FDA record for each
Peptide	Earliest dated approval
Ziconotide	2004
Drugs@FDA, NDA 021060, Prialt: approved December 28, 2004.
Trofinetide	2023
Drugs@FDA, NDA 217026, Daybue: approved March 10, 2023.

Other receptor-targeted peptides

Other receptor-targeted peptides: earliest dated FDA approval and the Drugs@FDA record for each
Peptide	Earliest dated approval
Icatibant	2011
Drugs@FDA, NDA 022150, Firazyr: approved August 25, 2011.
Etelcalcetide	2017
Drugs@FDA, NDA 208325, Parsabiv: approved February 7, 2017.
Angiotensin II	2017
Drugs@FDA, NDA 209360, Giapreza: approved December 21, 2017.
Difelikefalin	2021
Drugs@FDA, NDA 214916, Korsuva: approved August 23, 2021.
Motixafortide	2023
Drugs@FDA, NDA 217159, Aphexda: approved September 8, 2023.
Elamipretide	2025
Drugs@FDA, NDA 215244, Forzinity: approved September 19, 2025.
Icotrokinra	2026
Drugs@FDA, NDA 220149, Icotyde: approved March 17, 2026.
Enlicitide	2026
Drugs@FDA, NDA 220848, Lipfendra: approved July 15, 2026.
Rusfertide	2026
Drugs@FDA, NDA 220605, Mimrylo: approved August 28, 2026.

Radiolabeled peptides for imaging and therapy

Radiolabeled peptides for imaging and therapy: earliest dated FDA approval and the Drugs@FDA record for each
Peptide	Earliest dated approval
Indium In 111 pentetreotide	1994
Drugs@FDA, NDA 020314, Octreoscan: approved June 2, 1994.
Gallium Ga 68 dotatate	2016
Drugs@FDA, NDA 208547, Netspot: approved June 1, 2016.
Lutetium Lu 177 dotatate	2018
Drugs@FDA, NDA 208700, Lutathera: approved January 26, 2018.
Copper Cu 64 dotatate	2020
Drugs@FDA, NDA 213227, Detectnet: approved September 3, 2020.

Which new peptide drugs did the FDA approve from 2024 to 2026?

New peptide drugs approved since 2024 include palopegteriparatide in 2024, elamipretide in 2025, and navepegritide, icotrokinra, enlicitide and rusfertide in 2026.

Sources: FDA, Novel Drug Approvals for 2024, 2025 and 2026 (the 2026 list was last updated October 20, 2026).

Peptide drugs FDA approved from 2024 to 2026, with what each FDA label says
Approved	Peptide	What its FDA label says
August 9, 2024	Palopegteriparatide	A prodrug of PTH(1-34), the first 34 amino acids of human parathyroid hormone
Drugs@FDA, NDA 216490, Yorvipath; Yorvipath label on DailyMed.
September 19, 2025	Elamipretide	A peptide with the sequence D-Arg-2,6-dimethyl-Tyr-Lys-Phe-NH2
Drugs@FDA, NDA 215244, Forzinity; Forzinity label on DailyMed.
February 27, 2026	Navepegritide	A C-type natriuretic peptide analog whose CNP part has 38 amino acids
Drugs@FDA, NDA 219164, Yuviwel; Yuviwel label on DailyMed.
March 17, 2026	Icotrokinra	A 13-amino acid peptide
Drugs@FDA, NDA 220149, Icotyde; Icotyde label on DailyMed.
July 15, 2026	Enlicitide	A macrocyclic peptide
Drugs@FDA, NDA 220848, Lipfendra; Lipfendra label on DailyMed.
August 28, 2026	Rusfertide	A synthetic cyclic peptide
Drugs@FDA, NDA 220605, Mimrylo; Mimrylo label on DailyMed.

Bulevirtide, approved May 22, 2026, is not in this table. FDA licensed it as a biologic, and its label calls it a 47-amino-acid protein, although CDEK counts it as a peptide.

Sources: Drugs@FDA, BLA 761468, Hepcludex; Hepcludex label on DailyMed; CDEK.

How can you check whether a peptide is FDA approved?

Search the ingredient in Drugs@FDA, open its application to see the approval date and label, and read the current label on DailyMed.

Search Drugs@FDA. Type the ingredient, such as octreotide, into Drugs@FDA. It lists FDA-approved drugs only, by brand name, ingredient or application number.
Open the application. Its page shows the original approval date, and for most drugs approved since 1998 it also holds the label and the approval letter.
Read the current label. DailyMed, run by the National Library of Medicine, shows the label in use. Drugs marked unapproved there have not been approved by FDA.
No match? Check the Purple Book, which lists licensed biologics such as tesamorelin. Drugs@FDA also leaves out products still under review and dietary supplements, which need no FDA approval.

Sources: FDA, Drugs@FDA Frequently Asked Questions; FDA, About Drugs@FDA; NLM, About DailyMed; FDA, Purple Book Search.

Which 7 peptides did the FDA review for compounding in 2026?

On July 23 and 24, 2026, an FDA advisory committee reviewed BPC-157, KPV, TB-500, MOTS-c, emideltide (DSIP), epitalon and semax for pharmacy compounding. FDA’s own briefing papers proposed adding none of them to the list pharmacies may use.

Sources: FDA, July 23-24, 2026 meeting page; FDA briefing introduction, points 1 to 14.

The seven peptides the FDA committee reviewed in July 2026, with FDA's proposal and approval status
Peptide	Reviewed	FDA’s proposal	In an FDA-approved drug?
BPC-157	July 23	Do not add it, as free base or acetate	No
FDA briefing document for BPC-157 (no USP monograph; not a component of an FDA-approved drug); briefing introduction, points 1 and 2.
KPV	July 23	Do not add it, as free base or acetate	No
FDA briefing document for KPV (no USP monograph; not a component of an FDA-approved drug); briefing introduction, points 3 and 4.
TB-500	July 23	Do not add it, as free base or acetate	No
FDA briefing document for TB-500 (no USP monograph; not a component of an FDA-approved drug); briefing introduction, points 5 and 6.
MOTS-c	July 23	Do not add it, as free base or acetate	No
FDA briefing document for MOTS-c (no USP monograph; not a component of an FDA-approved drug); briefing introduction, points 7 and 8.
Emideltide (DSIP)	July 24	Do not add it, as free base or acetate	No
FDA briefing document for emideltide (no USP monograph; not a component of an FDA-approved drug); briefing introduction, points 9 and 10.
Epitalon	July 24	Do not add it, as free base or acetate	No
FDA briefing document for epitalon (no USP monograph; not a component of an FDA-approved drug); briefing introduction, points 11 and 12.
Semax	July 24	Do not add it, as free base or acetate	No
FDA briefing document for semax (no USP monograph; not a component of an FDA-approved drug); briefing introduction, points 13 and 14.

FDA reviewed each peptide in two forms, the free base and the acetate salt, so its briefing introduction lists 14 proposals in all. Every nomination had been withdrawn by the people who filed it, and FDA chose to bring the substances to the committee anyway.

Source: FDA briefing introduction, July 23-24, 2026.

The committee advises; it does not decide. FDA's meeting page says the advice of advisory committees is not binding. The briefing papers add that FDA will not make a final decision until it has weighed the committee's input. When we checked on November 5, 2026, the meeting page listed no minutes, so this page does not repeat vote counts reported elsewhere.

The 503A Bulks List names substances pharmacies may use in compounding when no official USP standard exists for them and no approved drug contains them. Being on it would not make anything an approved drug, because compounded drugs are not FDA-approved. For buying and importing, see are peptides legal.

Outside the United States, the FDA briefing on semax notes that it is a registered drug in Russia. For BPC-157, the FDA briefing reports that a search found it in no approved product in any country.

Sources: FDA meeting page; FDA briefing introduction; FDA, Compounding and the FDA; FDA briefing document for semax; FDA briefing document for BPC-157.

What are the most researched peptides?

Of the compounds searched here, octreotide has the most PubMed records: 9,396. Of the seven peptides the FDA committee reviewed in 2026, emideltide (DSIP) has the most, with 443. BPC-157 has 230, and none is tagged as a clinical trial.

Source: PubMed, searched November 5, 2026, 13:35 UTC; the exact query is under each row.

How to read the tables. All records counts PubMed records that name the compound in the title or abstract. Each other column adds one filter. Clinical trials are records PubMed tags as a clinical trial. Animal only are records tagged with animals but not humans. Cell studies are records tagged with cultured cells or cell lines. The columns overlap, and new records are not tagged right away, so they do not add up to the total. A trial record can measure a peptide the body makes rather than test it as a drug.

Filters added to each query: "clinical trial"[pt] for clinical trials; animals[mh] NOT humans[mh] for animal only; "cells, cultured"[mh] OR "cell line"[mh] for cell studies.

The seven peptides the FDA committee reviewed in 2026

PubMed records for the seven peptides the FDA committee reviewed in 2026
Compound	All records	Clinical trials	Animal only	Cell studies
Emideltide (DSIP)	443	17	314	11
PubMed query: "delta sleep-inducing peptide"[tiab] OR "delta sleep inducing peptide"[tiab] OR "emideltide"[tiab] OR ("DSIP"[tiab] AND (sleep[tiab] OR peptide[tiab] OR peptides[tiab]))DSIP is counted only beside the words sleep or peptide, because the letters also stand for unrelated terms. 15 of the 17 trial records are from 1981 to 1998.
MOTS-c	269	5	54	28
PubMed query: "MOTS-c"[tiab] OR "MOTSc"[tiab]Read by hand: the 5 trial records measured the MOTS-c the body makes, and none tested MOTS-c as a drug.
BPC-157	230	0	107	9
PubMed query: "BPC-157"[tiab] OR "BPC157"[tiab] OR "BPC 157"[tiab]
Semax	210	4	145	15
PubMed query: "semax"[tiab]
Epitalon	121	1	80	15
PubMed query: "epitalon"[tiab] OR "epithalon"[tiab] OR "epithalone"[tiab]
KPV	52	0	14	12
PubMed query: "KPV"[tiab] AND (peptide[tiab] OR peptides[tiab] OR tripeptide[tiab] OR "lysine-proline-valine"[tiab] OR "Lys-Pro-Val"[tiab] OR melanocortin[tiab] OR "melanocyte-stimulating hormone"[tiab] OR "alpha-MSH"[tiab])KPV is counted only beside peptide or melanocortin terms, because the letters are also an unrelated abbreviation.
TB-500	27	0	3	1
PubMed query: ("TB-500"[tiab] OR "TB500"[tiab]) AND (peptide[tiab] OR peptides[tiab] OR peptidic[tiab] OR thymosin[tiab] OR "thymosin β4"[tiab] OR doping[tiab])Narrowed to records that also say peptide, thymosin or doping, which removed 8 unrelated records.

Thymosin beta-4, the 43-amino-acid molecule that TB-500 is a fragment of, has 1,179 PubMed records. The FDA briefing on TB-500 says the two are not the same substance, so those records are not counted for TB-500.

Sources: PubMed query "thymosin beta-4"[tiab] OR "thymosin beta 4"[tiab] OR "thymosin β4"[tiab] OR "Tβ4"[tiab]; FDA briefing document for TB-500.

Approved peptide drugs, for scale

PubMed records for a sample of FDA-approved peptide drugs
Compound	All records	Clinical trials	Animal only	Cell studies
Octreotide	9,396	967	950	681
PubMed query: "octreotide"[tiab]
Semaglutide	5,845	346	278	58
PubMed query: "semaglutide"[tiab]
Liraglutide	5,727	616	833	264
PubMed query: "liraglutide"[tiab]
Teriparatide	3,077	321	183	36
PubMed query: "teriparatide"[tiab]
Leuprolide	2,990	668	312	105
PubMed query: "leuprolide"[tiab] OR "leuprorelin"[tiab]Includes leuprorelin, another name for leuprolide in NLM MeSH.
Tirzepatide	2,739	146	78	20
PubMed query: "tirzepatide"[tiab]
Elamipretide	441	19	155	55
PubMed query: "elamipretide"[tiab] OR "SS-31"[tiab]Includes SS-31, another name for elamipretide in NLM MeSH.
Bremelanotide	113	16	7	2
PubMed query: "bremelanotide"[tiab] OR "PT-141"[tiab]Includes PT-141, another name for bremelanotide in NLM MeSH.
Tesamorelin	95	23	1	0
PubMed query: "tesamorelin"[tiab]

Which investigational peptides are in late-stage trials?

Retatrutide, cagrilintide and survodutide each have Phase 3 studies listed on ClinicalTrials.gov. None has FDA approval, and Drugs@FDA had no application for any of them on November 5, 2026.

Sources: ClinicalTrials.gov, searched November 5, 2026; Drugs@FDA data through the openFDA Drugs@FDA API, searched the same day.

Investigational peptides with Phase 3 studies listed on ClinicalTrials.gov
Compound	How research describes it	Phase 3 studies listed
Retatrutide	A single peptide that acts on the GIP, GLP-1 and glucagon receptors	14
The Lancet, 2023, PMID 37385280; ClinicalTrials.gov, retatrutide, Phase 3 filter.
Cagrilintide	A long-acting analog of the hormone amylin	23
Journal of Medicinal Chemistry, 2021, PMID 34288673; ClinicalTrials.gov, cagrilintide, Phase 3 filter.
Survodutide	A 29-amino acid peptide derived from glucagon	12
Diabetes Research and Clinical Practice, 2024, PMID 37330144; ClinicalTrials.gov, survodutide, Phase 3 filter.

A missing Drugs@FDA entry is expected for these compounds, because Drugs@FDA does not include products still under review at FDA.

Source: FDA, Drugs@FDA Frequently Asked Questions.

What do Peptara Labs certificates of analysis show?

Across the published Peptara Labs certificates of analysis, measured purity by HPLC runs from 95.48 to 99.62 percent.

Source: the released certificates on our certificates page, read when this page is built. An independent third-party lab, named on each certificate, issues them.

A certificate shows what is in one batch. It does not make a compound FDA-approved, and a research vial is not one of the approved products in the tables above.

Some batches also have a second, independent endotoxin report from Janoshik, which can be checked by its key on Janoshik's own site. See Janoshik-tested batches.

Keep reading

Approval status, the law, and our lab results

What are peptides used for?

Approved, investigational and research-only peptides, by research area.

Are peptides legal?

What regulators and statutes say about buying and importing, country by country.

Certificates of analysis

Our released batch certificates from an independent lab, in full.

Janoshik-tested batches

Second, independent endotoxin reports that can be checked by key.

Peptide glossary: FDA-approved

The short definition, beside the other regulatory terms.

FDA-approved peptides: FAQ

Are collagen peptides FDA approved?

A collagen peptide sold as a dietary supplement has no FDA approval. FDA says dietary supplements do not need its approval to be sold, and Drugs@FDA lists only FDA-approved drugs.

Source: FDA, Drugs@FDA Frequently Asked Questions.

What is MOTS-c, and is it FDA approved?

The FDA briefing paper of July 2026 describes MOTS-c as a synthetic version of a 16-amino-acid peptide from mitochondria. It also says MOTS-c is not part of any FDA-approved drug. Our MOTS-c page summarizes the research.

Source: FDA briefing document for MOTS-c, July 2026.

Are any research peptides also FDA-approved drugs?

Some molecules sold for research share a name with an approved drug. Tesamorelin was approved in 2010, bremelanotide (also called PT-141) in 2019, and elamipretide (also called SS-31) in 2025. The approval covers only the approved product and its label, so a research vial of the same molecule has no FDA approval of its own.

Sources: Drugs@FDA, BLA 022505; NDA 210557; NDA 215244; NLM MeSH, bremelanotide and elamipretide.

Is a compounded peptide FDA approved?

No. FDA states that compounded drugs are not FDA-approved, and no compounded product goes through FDA review for safety, effectiveness or quality before it is sold.

Source: FDA, Compounding and the FDA: Questions and Answers.

Sources

Every source below is public and non-commercial, and each was opened and read on November 5, 2026. FDA records change, so check the live record before you rely on any line here.

Drugs@FDA: FDA-Approved DrugsU.S. Food and Drug Administration. One application page per drug in the class lists, each opened for its original approval date.
Drugs@FDA Frequently Asked QuestionsU.S. Food and Drug Administration. What Drugs@FDA includes and leaves out, including dietary supplements and investigational products.
About Drugs@FDAU.S. Food and Drug Administration. Coverage of the database, including the note that most records since 1998 carry labels and letters.
Development and Approval Process: DrugsU.S. Food and Drug Administration. What FDA approval of a drug means.
Understanding Unapproved Use of Approved Drugs "Off Label"U.S. Food and Drug Administration. Approval covers the uses on the label.
Compounding and the FDA: Questions and AnswersU.S. Food and Drug Administration. Compounded drugs are not FDA-approved.
Deemed to be a License Provision of the BPCI ActU.S. Food and Drug Administration. Peptides are polymers of 40 or fewer amino acids; insulin is named among the protein products.
List of Approved NDAs for Biological Products That Were Deemed to be BLAs on March 23, 2020U.S. Food and Drug Administration. Lists lixisenatide and tesamorelin acetate.
21 CFR 600.3, Definitions, paragraph (h)(6)Electronic Code of Federal Regulations. A protein is an amino acid polymer with a defined sequence of more than 40 amino acids.
Purple Book SearchU.S. Food and Drug Administration. Where licensed biologics, such as tesamorelin since 2020, are listed.
About DailyMedNational Library of Medicine, National Institutes of Health. Current drug labels; drugs marked unapproved there have not been approved by FDA.
CDEK, FDA Approvals: PeptideClinical Drug Experience Knowledgebase, Center for Research Innovation in Biotechnology (Purdue University College of Pharmacy and Stony Brook University). Counts drawn from Drugs@FDA and the Purple Book, without older approvals.
Trends in peptide drug discoveryMuttenthaler M, King GF, Adams DJ, Alewood PF. Nature Reviews Drug Discovery, 2021. PMID 33536635. More than 80 peptide drugs have reached the market since insulin was introduced.
2025 FDA TIDES (Peptides and Oligonucleotides) HarvestAlShaer D, Al Musaimi O, Albericio F, de la Torre BG. Pharmaceuticals, 2026. PMID 41754785. One peptide among the 46 novel drugs FDA approved in 2025.
2023 FDA TIDES (Peptides and Oligonucleotides) HarvestAl Shaer D, Al Musaimi O, Albericio F, de la Torre BG. Pharmaceuticals, 2024. PMID 38399458. Describes trofinetide as an ultrashort tripeptide.
Novel Drug Approvals for 2024, 2025 and 2026U.S. Food and Drug Administration, Center for Drug Evaluation and Research. The 2026 list was last updated October 20, 2026.
July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory CommitteeU.S. Food and Drug Administration. Agenda, briefing documents, questions and presentations. Content current as of August 6, 2026.
FDA Briefing Document, Pharmacy Compounding Advisory Committee, July 23-24, 2026 (introduction)U.S. Food and Drug Administration. FDA proposed that none of the 14 substances be placed on the 503A Bulks List.
PubMedNational Library of Medicine, National Institutes of Health. Record counts searched November 5, 2026, 13:35 UTC, with the exact queries shown under each row.
MeSH records for elamipretide, bremelanotide, leuprolide and sermorelinNational Library of Medicine, National Institutes of Health. Other names (SS-31, PT-141, leuprorelin) and the GHRH(1-29) definition of sermorelin.
ClinicalTrials.govNational Library of Medicine, National Institutes of Health. Phase 3 study counts by intervention.

Educational and research information only. Peptara Labs supplies research-grade compounds and is not a medical provider. Nothing here is medical or legal advice, and nothing here tells anyone what to take.