News and updates
Last reviewed October 29, 2026.
Dated changes that affect the compounds in this library: FDA approvals and actions, compounding policy, the WADA list and major trial results. Each entry links to the primary or official source. Newest first.
- BPC-157
HHS lets 503A pharmacies compound six peptides under an interim enforcement discretion policy
HHS issued an interim policy saying it does not intend to take enforcement action against state-licensed pharmacies, federal facilities or licensed physicians that compound BPC-157, Epitalon, KPV, MOTS-c, Semax or TB-500 under set conditions, such as a patient-specific prescription, ingredients from an FDA-registered facility with a certificate of analysis, single-ingredient products, approved routes only, and reporting of serious side effects to FDA. The policy is not an FDA approval, is non-binding, and lasts only until each peptide is addressed in a final rule on the 503A bulks list. A notice was filed with the Federal Register on October 28 for publication on October 30, with a two-week comment period.
Compounds: BPC-157, Epitalon, KPV, MOTS-c, Semax, TB-500 / Thymosin beta-4
Sources: Federal Register (public inspection): HHS notice, Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances (filed Oct 28, 2026) · HHS: Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances (policy text with appendices)
- Retatrutide
Retatrutide beats Ozempic on blood sugar and weight in head-to-head TRANSCEND-T2D-2 trial
Eli Lilly reported topline results from TRANSCEND-T2D-2, an 80-week, open-label phase 3 trial in 1,298 adults with type 2 diabetes that compared retatrutide with semaglutide (Ozempic) 2 mg. Both retatrutide doses lowered A1C by about 2.2 percentage points versus 1.8 with semaglutide, and average weight loss was roughly 20% versus 9.4%. Side effects were mainly gastrointestinal, and the data have not yet been peer reviewed.
Compounds: Retatrutide, Semaglutide
Sources: Lilly: Retatrutide delivered greater A1C reduction and more than double the weight loss of Ozempic's highest approved dose in head-to-head trial · PR Newswire: Lilly's retatrutide head-to-head trial vs. Ozempic
- Insulin
FDA extends once-weekly insulin icodec (Awiqli) to children 10 and older with type 2 diabetes
The FDA approved Novo Nordisk's once-weekly basal insulin icodec (Awiqli) for children aged 10 and older with type 2 diabetes, extending an approval previously limited to adults. The decision relied on the adult ONWARDS trial program plus a pharmacokinetic study in adolescents. Safety and effectiveness in children under 10 have not been established.
Compounds: Insulin
Sources: Novo Nordisk US press release: FDA approval of Awiqli for children 10 and older with type 2 diabetes · AJMC: FDA Extends Once-Weekly Insulin to Youth With Type 2 Diabetes
- BPC-157
Citizen petition asks FDA not to allow compounding of seven peptides reviewed by its advisory committee
The Partnership for Safe Medicines, a drug-safety advocacy group, filed a citizen petition asking FDA not to permit compounding with BPC-157, KPV, TB-500, MOTS-c, emideltide (DSIP), Semax or epitalon, whether through the 503A bulks list, Category 1 placement or enforcement discretion. The petition also argues that the July 2026 Pharmacy Compounding Advisory Committee meeting was improperly constituted and should not be relied on for rulemaking. FDA had not responded at the time of filing; the petition was resubmitted on October 23 to correct a signature issue.
Compounds: BPC-157, KPV, TB-500 / Thymosin beta-4, MOTS-c, DSIP, Semax, Epitalon
Sources: Citizen petition to FDA (submitted via Regulations.gov, Oct 23, 2026) · Partnership for Safe Medicines press release (Oct 21, 2026) · RAPS: This Week at FDA: Peptide dispute, clinical trial legislation, and more
- Survodutide
Survodutide SYNCHRONIZE-2 phase 3 results in obesity with type 2 diabetes published in NEJM
Boehringer Ingelheim presented the phase 3 SYNCHRONIZE-2 trial at EASD 2026, with simultaneous publication in the New England Journal of Medicine. In 755 adults with obesity or overweight and type 2 diabetes, weekly survodutide led to up to 13.1% average weight loss over 76 weeks versus 3.1% with placebo, and lowered HbA1c by up to 1.21 percentage points. Gastrointestinal side effects were the most common reason for stopping treatment; survodutide remains investigational.
Compounds: Survodutide
Sources: Boehringer Ingelheim: New Phase III data in people with obesity and diabetes
- Eloralintide
EloraTZP (eloralintide plus tirzepatide) phase 2 results presented at EASD 2026
Eli Lilly reported a 48-week phase 2 trial in 367 adults with obesity or overweight and type 2 diabetes that tested the amylin agonist eloralintide combined with tirzepatide. The highest-dose combination produced average weight loss of 23.3% versus 14.8% with tirzepatide alone and 3.0% with placebo, with larger A1C reductions as well. Gastrointestinal side effects were more frequent with the combination, and Lilly said it plans to start phase 3 trials in the fourth quarter of 2026.
Compounds: Eloralintide, Tirzepatide
- Orforglipron
Orforglipron ACHIEVE-4 cardiovascular safety trial published in The Lancet
Full results of ACHIEVE-4, the largest and longest phase 3 trial of the oral GLP-1 drug orforglipron (Foundayo) in type 2 diabetes, were presented at EASD 2026 and published in The Lancet. Compared with insulin glargine in adults at increased cardiovascular risk, orforglipron met its cardiovascular safety (non-inferiority) goal, though the reduction in major cardiovascular events was not statistically significant. At 52 weeks it lowered A1C by 1.6 points versus 1.0 and reduced body weight by 8.8% versus a 1.7% gain.
Compounds: Orforglipron
- Retatrutide
Full TRIUMPH-2 retatrutide results published in The Lancet
Complete results of the phase 3 TRIUMPH-2 trial of retatrutide in 1,152 adults with obesity or overweight and type 2 diabetes were published in The Lancet and presented at EASD 2026, following the July topline announcement. Over 80 weeks, average weight loss reached about 21% at the highest dose versus 4% with placebo, alongside A1C reductions of up to 1.6 points. Gastrointestinal effects were most common, and Lilly said it plans to file for FDA approval in early 2027.
Compounds: Retatrutide
Sources: Lilly: Retatrutide delivered substantial weight loss and A1C reduction in people with obesity and type 2 diabetes (TRIUMPH-2) · The Lancet: Retatrutide in adults with obesity and type 2 diabetes (TRIUMPH-2)
- Insulin
FDA approves insulin efsitora alfa (Onswik), a once-weekly basal insulin for type 2 diabetes
The FDA approved Eli Lilly's insulin efsitora alfa (Onswik), a once-weekly basal insulin, for adults with type 2 diabetes. The approval was based on four phase 3 QWINT trials in more than 3,400 adults that compared it with daily insulin glargine or degludec and showed non-inferior A1C reduction. It is not approved for type 1 diabetes or for children.
Compounds: Insulin
Sources: Eli Lilly (PR Newswire): FDA approves Lilly's Onswik (insulin efsitora alfa-gobe)
- BPC-157
WADA publishes 2027 Prohibited List, naming peptides as examples of non-approved substances
WADA published its 2027 Prohibited List, which takes effect on January 1, 2027. Peptides are now named as examples in the S0 (non-approved substances) class, with WADA cautioning that unapproved peptides not listed by name may still be prohibited, and SLU-PP-332 was added as an example of a metabolic modulator under S4. Semaglutide and tirzepatide stay in the monitoring program in and out of competition, which means labs track their use but they are not prohibited.
Compounds: BPC-157, SLU-PP-332, Semaglutide, Tirzepatide
Sources: WADA: 2027 Prohibited List · WADA: 2027 List summary of major modifications and explanatory notes · WADA: 2027 Monitoring Program · USADA athlete advisory: What's new on the 2027 WADA Prohibited List
- Cagrilintide
CagriSema beats low-dose tirzepatide on weight loss in REIMAGINE 5; REDEFINE 9 succeeds
Novo Nordisk reported two phase 3 readouts for CagriSema (cagrilintide plus semaglutide). In REIMAGINE 5, adults with type 2 diabetes lost 12.4% of body weight on CagriSema 1.0/1.0 mg versus 9.1% on tirzepatide 5 mg over 60 weeks, with similar A1C lowering. In REDEFINE 9, adults with overweight or obesity lost 21.0% versus 2.0% with placebo over 68 weeks; an FDA decision on CagriSema is expected in the fourth quarter of 2026.
Compounds: Cagrilintide, Semaglutide, Tirzepatide
Sources: Novo Nordisk: Novo's CagriSema delivers superior weight loss versus tirzepatide in REIMAGINE 5 trial
- Semaglutide
FDA warning letter cites large compounding pharmacy over semaglutide and tirzepatide copies
The FDA issued a warning letter to a large Texas 503A compounding pharmacy after a November 2025 inspection. The agency said the pharmacy regularly compounded semaglutide and tirzepatide preparations (combined with vitamins) that were essentially copies of approved drugs, and cited sterile-processing and quality-control problems. The letter was posted on fda.gov on September 22, 2026.
Compounds: Semaglutide, Tirzepatide
- Vosoritide
BioMarin submits vosoritide (Voxzogo) to the FDA for hypochondroplasia
BioMarin said on September 9, 2026 that it had recently filed a supplemental application asking the FDA to approve vosoritide for children with hypochondroplasia. The application follows a phase 3 trial in which treated children grew faster than those on placebo; those results were published in NEJM Evidence. No FDA decision date was announced for this application.
Compounds: Vosoritide
Sources: BioMarin press release: Phase 3 Voxzogo hypochondroplasia results published in NEJM Evidence
- Tirzepatide
FDA approves tirzepatide (Mounjaro) to lower cardiovascular risk in type 2 diabetes
The FDA approved Mounjaro (tirzepatide) to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes who are at high cardiovascular risk. The approval was based on the SURPASS-CVOT trial of about 13,300 people, which compared tirzepatide with dulaglutide and found it non-inferior; it did not show that tirzepatide was superior.
Compounds: Tirzepatide, Dulaglutide
FDA approves rusfertide (Mimrylo), a hepcidin-mimetic peptide for polycythemia vera
The FDA approved rusfertide (Mimrylo), an injected peptide that mimics the iron-regulating hormone hepcidin, for adults with polycythemia vera that is not adequately controlled with existing therapy. In the phase 3 VERIFY trial, 76.9% of patients on rusfertide met the response criteria for avoiding phlebotomy, compared with 32.9% on placebo. It is the first drug of its kind approved for this rare blood disorder.
Sources: FDA: FDA Approves First Drug of Its Kind for Polycythemia Vera, a Rare Blood Disorder
- Glutathione
FDA warns compounders against injectable glutathione made from supplement-grade ingredient after illnesses
FDA reminded compounders not to use dietary-supplement-grade glutathione to make injectable drugs after at least 30 people reported adverse events following IV glutathione, with symptoms consistent with endotoxin exposure. CDC separately reported more than 25 illnesses across Texas, Washington, Florida and New York, including at least three hospitalizations, and two Texas pharmacies recalled glutathione products.
Compounds: Glutathione
Sources: FDA reminds compounders not to use dietary supplement grade glutathione for injectables · CDC: Adverse events linked to injectable glutathione compounded with dietary supplement grade ingredient
- Semaglutide
FDA warns online 'research peptide' sellers over unapproved retatrutide, semaglutide and tirzepatide
The FDA sent warning letters to online firms selling products labeled as semaglutide, tirzepatide, retatrutide, survodutide, mazdutide, tesamorelin, bremelanotide (PT-141) and elamipretide (SS-31) as 'research peptides.' The agency said website claims and the sale of bacteriostatic water for injection showed the products were intended for human use. It said a 'research use only' label did not change its finding that they are unapproved new drugs. The letters were posted on fda.gov on September 1, 2026.
Compounds: Semaglutide, Tirzepatide, Retatrutide, Survodutide, Mazdutide, Tesamorelin, PT-141, SS-31
Sources: FDA warning letter 733652 (August 24, 2026) · FDA warning letter 735063 (August 24, 2026)
- Retatrutide
Retatrutide succeeds in TRIUMPH-2 and TRIUMPH-3 phase 3 trials
Eli Lilly reported topline results from two 80-week phase 3 trials of retatrutide, an investigational weekly GIP/GLP-1/glucagon agonist. Average weight loss reached 20.8% in people with type 2 diabetes (TRIUMPH-2) and 22.6% in people with severe obesity and heart disease (TRIUMPH-3); cardiovascular event results were not statistically significant. Lilly plans to file with the FDA in early 2027.
Compounds: Retatrutide
- BPC-157
FDA advisory committee votes on seven peptides for the 503A compounding list
Over July 23–24, 2026, the FDA's Pharmacy Compounding Advisory Committee voted, mostly by narrow margins, to recommend adding BPC-157, KPV, TB-500, MOTS-c, Epitalon and Semax to the list of substances pharmacies may use in compounding; it voted against emideltide (DSIP). The votes are advisory only: the FDA is not bound by them, and any listing would require later rulemaking.
Compounds: BPC-157, KPV, TB-500 / Thymosin beta-4, MOTS-c, Epitalon, Semax, DSIP
Sources: FDA: July 23-24, 2026 Meeting of the Pharmacy Compounding Advisory Committee · RAPS Regulatory Focus: FDA advisory committee backs two controversial peptides · McDermott Will & Schulte: PCAC backs majority of peptides in two-day public meeting
- Retatrutide
Retatrutide TRIUMPH-1 phase 3 results: up to 28.3% weight loss
Eli Lilly reported that in the 80-week TRIUMPH-1 trial in 2,339 adults with obesity or overweight without diabetes, the 12 mg dose of retatrutide produced an average weight loss of 28.3% versus 2.2% with placebo (efficacy estimand); in the 104-week extension the figure was 30.3%. Gastrointestinal side effects and dysesthesia (abnormal skin sensations) were more common at higher doses. Retatrutide remains investigational.
Compounds: Retatrutide
Sources: Eli Lilly press release: TRIUMPH-1 topline results (May 21, 2026)
- Survodutide
Survodutide meets endpoints in phase 3 SYNCHRONIZE-1 obesity trial
Boehringer Ingelheim reported that its investigational glucagon/GLP-1 dual agonist survodutide produced average weight loss of up to 16.6% at 76 weeks versus 3.2% with placebo in 725 adults with obesity or overweight without type 2 diabetes. Side effects were mainly gastrointestinal, in line with the GLP-1 class.
Compounds: Survodutide
Sources: Boehringer Ingelheim release via GlobeNewswire (April 28, 2026) · BioPharm International: Dual agonist survodutide shows significant weight loss in phase III obesity trial
- BPC-157
FDA moves 12 peptides out of compounding Category 2 and schedules advisory review
The FDA announced it would remove 12 peptides, including BPC-157, TB-500, KPV, MOTS-c, Semax, Epitalon and DSIP, from Category 2 (bulk substances that raise significant safety concerns) and published a Federal Register notice on April 16 scheduling advisory committee review of seven of them. Five more (LL-37, GHK-Cu, Dihexa, Melanotan II and PEG-MGF) are slated for review before the end of February 2027. Removal from Category 2 does not by itself make these substances eligible for compounding.
Compounds: BPC-157, TB-500 / Thymosin beta-4, KPV, MOTS-c, Semax, Epitalon, DSIP, LL-37, GHK-Cu, Dihexa, Melanotan II, Mechano growth factor (MGF) and PEG-MGF
Sources: Federal Register: Pharmacy Compounding Advisory Committee; notice of meeting (FR Doc. 2026-07361) · Goodwin: FDA signals potentially evolving stance toward compounding of certain peptides
- Orforglipron
FDA approves orforglipron (Foundayo), an oral GLP-1 pill for obesity
The FDA approved Eli Lilly's Foundayo (orforglipron), a once-daily non-peptide GLP-1 receptor agonist tablet, for chronic weight management in adults with obesity or overweight with a weight-related condition. It was the first new molecular entity approved under the FDA's Commissioner's National Priority Voucher program. Like other GLP-1 drugs, it carries a boxed warning about thyroid C-cell tumors.
Compounds: Orforglipron
Sources: FDA: FDA approves first new molecular entity under national priority voucher program
- Semaglutide
FDA approves Wegovy HD (semaglutide 7.2 mg)
The FDA approved a higher 7.2 mg once-weekly dose of injectable semaglutide, branded Wegovy HD, for weight reduction and long-term weight maintenance. In the STEP UP trial, average weight loss was 20.7% for people who stayed on treatment.
Compounds: Semaglutide
Sources: Novo Nordisk: Wegovy HD (semaglutide 7.2 mg) approved in the US (March 19, 2026)
- Setmelanotide
FDA approves setmelanotide (Imcivree) for acquired hypothalamic obesity
The FDA expanded the approval of setmelanotide (Imcivree) to cover acquired hypothalamic obesity, which typically follows damage to the hypothalamus, in patients aged 4 and older. In the phase 3 TRANSCEND trial, BMI fell by 15.8% at 52 weeks on setmelanotide versus a 2.6% increase on placebo.
Compounds: Setmelanotide
Sources: Rhythm Pharmaceuticals press release (SEC Form 8-K exhibit, March 19, 2026)
- Cagrilintide
CagriSema misses non-inferiority goal against tirzepatide in REDEFINE 4
In the 84-week, open-label REDEFINE 4 trial, CagriSema (cagrilintide plus semaglutide) produced 23.0% average weight loss versus 25.5% with tirzepatide 15 mg in adherent participants, so it did not meet its primary goal of showing non-inferiority to tirzepatide. Novo Nordisk said an FDA decision on CagriSema is expected by late 2026.
Compounds: Cagrilintide, Semaglutide, Tirzepatide
Sources: Novo Nordisk company announcement: REDEFINE 4 results (February 23, 2026)
- Semaglutide
FDA approves Wegovy pill, oral semaglutide 25 mg for weight management
Novo Nordisk announced FDA approval of a once-daily 25 mg semaglutide tablet (Wegovy pill), the first oral GLP-1 receptor agonist approved for weight management, and for reducing the risk of major cardiovascular events. In the OASIS 4 trial, average weight loss was 16.6% among people who stayed on treatment.
Compounds: Semaglutide
- Cagrilintide
Novo Nordisk submits CagriSema to the FDA
Novo Nordisk filed a New Drug Application with the FDA for once-weekly CagriSema (cagrilintide 2.4 mg plus semaglutide 2.4 mg) for weight management, based mainly on the REDEFINE 1 trial. If approved, it would be the first injectable combination of a GLP-1 agonist and an amylin analogue.
Compounds: Cagrilintide, Semaglutide
Sources: Novo Nordisk: Files for FDA approval of CagriSema (December 18, 2025)
- Eloralintide
Eloralintide phase 2 results published in The Lancet
Eli Lilly reported that its investigational selective amylin agonist eloralintide produced up to 20.1% average weight loss at 48 weeks versus 0.4% with placebo in a 263-person phase 2 trial. The results were presented at ObesityWeek 2025 and published at the same time in The Lancet. Side effects were mainly mild-to-moderate gastrointestinal symptoms and fatigue.
Compounds: Eloralintide
Sources: Eli Lilly press release: eloralintide Phase 2 results (November 6, 2025)
- Semaglutide
WADA publishes 2026 Prohibited List; tirzepatide added to GLP-1 monitoring
WADA published its 2026 Prohibited List, in force from January 1, 2026, adding examples and clarifications to the peptide hormone class (S2), including the EPO-mimetic pegmolesatide. Its Monitoring Program, which tracks use but does not ban, now covers tirzepatide alongside semaglutide; GLP-1 drugs are not prohibited.
Compounds: Semaglutide, Tirzepatide
Sources: WADA Summary of Major Modifications and Explanatory Notes, 2026 Prohibited List (hosted by the International Testing Agency) · International Paralympic Committee: WADA publishes 2026 Prohibited List
- SS-31
FDA grants accelerated approval to elamipretide (Forzinity) for Barth syndrome
The FDA granted accelerated approval to Forzinity (elamipretide, also known as SS-31), a once-daily injection from Stealth BioTherapeutics, as the first treatment for Barth syndrome in patients weighing at least 30 kg. The approval rests on improved knee-extensor muscle strength, and a confirmatory placebo-controlled trial is required.
Compounds: SS-31
Sources: FDA: FDA grants accelerated approval for first treatment for Barth syndrome
- Orforglipron
ATTAIN-1: oral orforglipron phase 3 obesity results published in NEJM
The phase 3 ATTAIN-1 trial in 3,127 adults with obesity without diabetes found that once-daily orforglipron 36 mg reduced body weight by 11.2% at 72 weeks versus 2.1% with placebo. The results were published online in the New England Journal of Medicine.
Compounds: Orforglipron
- Semaglutide
FDA grants accelerated approval to Wegovy for MASH liver disease
The FDA approved semaglutide 2.4 mg (Wegovy) under accelerated approval for adults with noncirrhotic MASH (metabolic dysfunction-associated steatohepatitis) with moderate-to-advanced liver fibrosis. In part 1 of the ESSENCE trial, 36.8% of treated patients had improved fibrosis versus 22.4% on placebo.
Compounds: Semaglutide
Sources: Novo Nordisk: Wegovy approved in the US for MASH (August 15, 2025)
- Cagrilintide
REDEFINE 1 and 2 CagriSema results published in NEJM
Two phase 3 trials of cagrilintide plus semaglutide were published in the New England Journal of Medicine. In REDEFINE 1, adults without diabetes lost an average of 20.4% of body weight at 68 weeks versus 3.0% with placebo; gastrointestinal side effects affected about 80% of treated participants.
Compounds: Cagrilintide, Semaglutide
- Mazdutide
Mazdutide GLORY-1 phase 3 results published in NEJM
Innovent's phase 3 GLORY-1 trial in 610 Chinese adults with overweight or obesity, published in the New England Journal of Medicine, found average weight loss of 14.84% at 48 weeks with mazdutide 6 mg versus 0.47% with placebo. The most common side effects were nausea, diarrhea and vomiting.
Compounds: Mazdutide
Sources: Innovent press release: GLORY-1 published in NEJM (May 25, 2025)
- Semaglutide
FDA declares semaglutide shortage resolved, ending the compounding grace period
The FDA issued a declaratory order finding that the shortage of semaglutide injections (Ozempic and Wegovy) was resolved. Compounding pharmacies (503A) had until April 22, 2025, and outsourcing facilities (503B) until May 22, 2025, to stop making copies under the shortage exception. The tirzepatide shortage had been declared resolved on December 19, 2024.
Compounds: Semaglutide, Tirzepatide
Sources: FDA declaratory order: semaglutide injection shortage resolved (February 21, 2025) · FDA memo: resolution of tirzepatide injection product shortage (December 19, 2024)