Database Updates

Based on the SURPASS-CVOT trial (over 13,000 participants, 4.5 years), the FDA approved Mounjaro to reduce cardiovascular events (CV death, non-fatal MI, non-fatal stroke) in adults with type 2 diabetes at high CV risk (HR 0.92 vs dulaglutide). Tirzepatide becomes the first dual GIP/GLP-1 agonist with an approved cardiovascular indication.

On August 28, 2026, the FDA approved MIMRYLO (rusfertide, Takeda/Protagonist Therapeutics) for erythrocytosis in adults with polycythemia vera. First hepcidin mimetic peptide approved anywhere in the world. Phase 3 VERIFY trial: 76.9% of patients achieved clinical response with maintained hematocrit control and reduced phlebotomy burden during weeks 20-32.

In August 2026, two compounding pharmacies recalled multiple lots of glutathione 200 mg/mL injection due to elevated bacterial endotoxin levels, following 30+ adverse events including fever, chills, sepsis-like symptoms, and hospitalizations. The FDA issued a safety communication warning that dietary supplement grade glutathione is not appropriate for sterile injectable compounding. Medisca Inc. sent a stop-use warning to US customers on August 20, 2026.

Novo Nordisk's Awiqli (insulin icodec-abae, U-700) launched commercially at over 70,000 US pharmacies on August 11, 2026, following FDA approval on March 26, 2026. The once-weekly FlexTouch pen reduces basal insulin injections from 7 to 1 per week for adults with type 2 diabetes. Not approved for type 1 diabetes.

FDA PCAC votes July 23-24: 6 peptides recommended for 503A compounding bulks list; DSIP rejected

At the July 23-24, 2026 Pharmacy Compounding Advisory Committee meeting, the panel recommended six peptides for the 503A authorized bulks list: BPC-157 (8-6), KPV, TB-500 (8-6), MOTS-c (7-5), Epitalon, and Semax (8-5). Emideltide (DSIP) failed to receive a positive recommendation. These votes are non-binding advisory opinions; FDA must complete notice-and-comment rulemaking (typically 12-24 months) before any legal compounding change takes effect.

Eli Lilly announced positive topline results for TRIUMPH-2 (obesity plus type 2 diabetes) and TRIUMPH-3 (severe obesity plus established cardiovascular disease, n=1,949) on July 23, 2026. Participants on the 12 mg dose in TRIUMPH-3 lost an average of 22.6% of body weight over 80 weeks. Lilly's NDA filing is expected by late 2026 or early 2027.

The Skin Cancer Foundation issued a formal public warning on July 7, 2026 strongly discouraging use of Melanotan II and other unapproved tanning agents, citing case reports of melanoma, dysplastic nevus eruption, priapism requiring surgical intervention, rhabdomyolysis, and renal infarction. The Foundation urged consumers to avoid injectable or intranasal tanning drugs and consult a dermatologist about any lesion changes.

STAT News: new FDA PCAC panelists have financial ties to peptide compounding ahead of July meeting

STAT News reported on June 29, 2026 that the FDA named eight new members to the Pharmacy Compounding Advisory Committee, with the majority involved in businesses that prescribe or promote compounded peptides. UC Davis cell biology professor Paul Knoepfler and other critics raised conflict-of-interest concerns. The panel convenes July 23-24, 2026 to vote on whether to recommend BPC-157, TB-500, MOTS-c, KPV, DSIP, Semax, and Epitalon for the 503A Bulks List.

Rhythm Pharmaceuticals presented interim Phase 2 data for setmelanotide in Prader-Willi syndrome at ENDO 2026 in Chicago on June 13, 2026. Six-month results showed improvements in BMI, hyperphagia scores, body composition, and food-related anxiety, with a 25% decrease in concurrent anti-obesity medication use. Safety was consistent with the established setmelanotide profile. The company stated the results support advancing to Phase 3 in PWS.

On June 10, 2026 (the PDUFA target date), the FDA issued a second Complete Response Letter to Camurus for Oclaiz (CAM2029), an extended-release subcutaneous octreotide for acromegaly. The CRL is solely manufacturing-related: unresolved cGMP inspection observations at a third-party contract manufacturer remain outstanding. Clinical efficacy and safety data are not in question. Oclaiz holds marketing authorization in the EU and UK. Camurus plans to resubmit; no new PDUFA date has been announced.

On June 10, 2026 (the original PDUFA date), the FDA issued a Complete Response Letter for Camurus's Oclaiz (long-acting subcutaneous octreotide depot for acromegaly) citing manufacturing inspection deficiencies at a third-party facility; no clinical or safety concerns were raised. After remediation, the NDA was resubmitted and accepted with a new PDUFA target date of December 18, 2026. Oclaiz holds EU and UK authorization (as Oczyesa).

Phase 3 SYNCHRONIZE-1 (76 weeks, obesity): survodutide produced 16.6% mean weight loss vs 3.2% on placebo; 85.1% of patients achieved at least 5% weight loss. SYNCHRONIZE-MASLD (48 weeks, MASLD): 61% liver fat normalization, 84.2% achieved at least 30% liver fat reduction vs 24.3% on placebo. Both studies were presented at ADA 2026 and simultaneously published in NEJM and Nature Medicine. A US NDA was submitted in February 2026.

Full Phase 3 data for survodutide (Boehringer Ingelheim) were published June 7, 2026 and presented at ADA 2026 in New Orleans. SYNCHRONIZE-1 (NEJM) showed 16.6% mean body weight reduction at 76 weeks vs. 3.2% placebo. SYNCHRONIZE-MASLD (Nature Medicine) showed 84.2% of patients achieved 30%+ liver fat reduction vs. 24.3% in controls. Both trials met co-primary endpoints. Tolerability questions were raised at ADA 2026, with Boehringer Ingelheim defending the safety profile as consistent with the GLP-1 drug class.

CagriSema REIMAGINE 1-3 Phase 3 data meet primary endpoints in type 2 diabetes at ADA 2026

Novo Nordisk presented Phase 3 data from the REIMAGINE 1, 2, and 3 trials at ADA 2026 Scientific Sessions in New Orleans (June 5-8, 2026). CagriSema 2.4/2.4 mg met primary endpoints for HbA1c reduction across multiple background therapies in type 2 diabetes. REIMAGINE 2 also included a cagrilintide monotherapy arm supporting the standalone RENEW Phase 3 program. The existing NDA (filed December 2025) is under FDA review with a decision anticipated around October 2026; a higher-dose CagriSema Phase 3 is planned for H2 2026.

On April 29, 2026, Lannett/Lanexa/Sunshine Lake Pharma's Langlara (insulin glargine-aldy) was approved as an interchangeable biosimilar of Lantus. On May 29, 2026, the FDA approved MannKind's Afrezza inhaled insulin for children and adolescents aged 6 and older with T1D or T2D, based on the Phase 3 INHALE-1 trial. Afrezza is the first needle-free mealtime insulin approved for pediatric patients.

On May 29, 2026, the FDA approved Afrezza (insulin human) inhalation powder for mealtime use in children and adolescents aged 6 and older with type 1 or type 2 diabetes, making it the first and only inhaled mealtime insulin approved for pediatric patients. The supplemental BLA was supported by the Phase 3 INHALE-1 trial (n=230 youth aged 4-17). Manufacturer: MannKind Corporation.

On May 27, 2026, the FDA approved Linzess (linaclotide) for functional constipation in pediatric patients aged 2 and older, the first FDA-approved prescription therapy for this condition in children under 6. The approval expands the prior FC indication (ages 6 and older) down to age 2, based on a 12-week double-blind Phase 3 trial showing significantly improved spontaneous bowel movement frequency in patients aged 2-5 meeting modified Rome IV criteria.

The FDA approved a supplemental NDA on May 27, 2026 extending Linzess's pediatric functional constipation indication from children aged 6 down to age 2, based on a 12-week Phase 3 placebo-controlled trial in children aged 2-5. Linzess is now the only FDA-approved prescription therapy for functional constipation in patients aged 2 and older.

Eli Lilly reported topline data from TRIUMPH-1, the pivotal Phase 3 obesity trial for retatrutide (2,339 adults with obesity, no T2D). The 12 mg dose produced 28.3% mean body weight reduction at 80 weeks, with 45.3% of participants losing at least 30% of their body weight. Full data presentation is planned for ADA 2026 Scientific Sessions in June 2026. NDA submission is expected in late 2026 or Q1 2027.

Eli Lilly announced TRIUMPH-1 topline results for retatrutide (GLP-1/GIP/glucagon triple agonist): mean weight loss of 28.3% at the 12 mg dose over 80 weeks, with approximately half of participants reaching 30% weight loss - a threshold historically associated with bariatric surgery. The 9 mg dose produced approximately 26% and 4 mg approximately 19% weight loss. No NDA submission has been announced.

At the May 18-21, 2026 CHMP meeting, the EMA adopted positive opinions for Liraglutide Stada (STADA Arzneimittel AG) for type 2 diabetes in adults and children aged 10 and older, and Ablymico (STADA) for weight management in overweight and obese adults. Both are hybrid products bioequivalent to Victoza and Saxenda respectively. EU marketing authorizations are expected to follow the CHMP opinions in mid-2026.

The FDA approved two new 3-month strengths of Lupron Depot-PED (leuprolide acetate for depot suspension) - 11.25 mg and 30 mg - for central precocious puberty in children, reducing injection frequency from monthly to every 3 months. Supported by a 24-week open-label study in 84 pediatric patients. These new strengths expand the existing monthly Lupron Depot-PED line.

ECO 2026: CagriSema REDEFINE-1 DXA data show fat-predominant weight loss with no functional muscle decline

At the European Congress on Obesity (ECO 2026, Istanbul, May 2026), Novo Nordisk presented body composition data from the Phase 3 REDEFINE-1 trial (3,417 participants, 68 weeks). DXA sub-study results showed 66.9% of weight lost was fat mass; muscle strength tests showed no functional decline vs placebo. This secondary analysis supports the CagriSema NDA currently under FDA review.

Per Tonix Pharmaceuticals Q1 2026 earnings (May 11, 2026), initiation of the Phase 2 trial of TNX-2900 (intranasal potentiated oxytocin) in Prader-Willi syndrome hyperphagia has been delayed to Q1 2027 - not 2026 as previously reported. No patients have been enrolled. Orphan Drug and Rare Pediatric Disease designations remain in place, preserving eligibility for a Priority Review Voucher on approval.

On May 4, 2026, the FDA disclosed a single post-market liver failure case for Foundayo (orforglipron) via FAERS. Eli Lilly concluded the event was not causally related to the drug; analyses across seven Phase 3 trials showed no hepatic safety signal. As a condition of approval, FDA requires 5-year reporting of serious unexpected drug-induced liver injury cases and post-marketing clinical trials for cardiovascular events and DILI.

On May 4, 2026, Novo Nordisk retired the Rybelsus brand in the US and launched the improved R2 oral semaglutide formulation under the Ozempic brand name at 1.5 mg, 4 mg, and 9 mg doses for type 2 diabetes (FDA sNDA approved January 30, 2026). The R2 formulation has improved bioavailability: 1.5 mg R2 is bioequivalent to 3 mg of original Rybelsus. Novo Nordisk also reported positive Pioneer Teens Phase 3a results in adolescent type 2 diabetes and plans US and EU sNDA filings for pediatric use in H2 2026.

The February 2026 changelog entry incorrectly described a pending September 2026 PDUFA date for elamipretide. FORZINITY (elamipretide HCl) was granted FDA accelerated approval for Barth syndrome in September 2025, making it the first FDA-approved mitochondria-targeted therapeutic. The peptide database entry already reflects the correct status. Confirmatory trials are required under the terms of accelerated approval.

MOTS-c and humanin both shown to counteract steroid-induced muscle atrophy in human skeletal muscle cells

A 2026 PMC-indexed study (PMC12930096) found that both MOTS-c and humanin attenuated dexamethasone-induced muscle atrophy in human skeletal muscle cells, suppressing key atrophy markers. The study supports the mechanistic basis for using mitochondria-derived peptides in muscle-wasting conditions. No human clinical trial data exists for either peptide yet.

Two peer-reviewed 2026 publications add to the preclinical evidence base for FOXO4-DRI. A Frontiers in Bioengineering and Biotechnology study (PMC12852416) showed FOXO4-DRI reduces senescent endothelial cell burden and improves aortic vascular function in aged mice via the p53/BCL-2/Caspase-3 pathway. A Naunyn-Schmiedeberg's Archives of Pharmacology review proposed FOXO4-DRI as a strategy against brain aging, citing improved cognitive metrics in Alzheimer's and tauopathy models. Both are preclinical only.

Following the FDA approval on March 19, 2026, Imcivree received European Commission marketing authorization on May 1, UK MHRA expanded authorization on August 11, and Japan MHLW approval on August 24, 2026. Setmelanotide is now approved for acquired hypothalamic obesity in all four major markets, establishing it as the global standard of care for this rare condition.

On May 1, 2026, the European Commission approved Imcivree (setmelanotide) for obesity and hunger control in adults and children aged 4 and older with acquired hypothalamic obesity due to hypothalamic injury or impairment. This follows the FDA approval of March 19, 2026 and the CHMP positive opinion of March 26, 2026. Setmelanotide is now the first therapy approved by both the FDA and EC for this indication. EU commercial launches are anticipated in 2027 pending national access negotiations in individual member states.

ASHP drug shortage database shows both branded Somatuline (Ipsen) and generic lanreotide (Exelan) on back order with no estimated release date as of May 2026. Full supply is not expected until first half of FY2027, continuing the disruption from the January 2026 Class II recall triggered by FDA OAI action against manufacturer Pharmathen International.

FDA proposes to permanently exclude semaglutide, tirzepatide, and liraglutide from 503B bulk compounding

On May 1, 2026, the FDA published Federal Register notice 2026-08552 proposing to exclude semaglutide, tirzepatide, and liraglutide from the 503B outsourcing facility bulk drug substances list. The FDA cited resolved drug shortages and available approved commercial alternatives as the rationale. This is a proposed rule, not a final rule. Public comment period closes June 29, 2026. If finalized, 503B compounding pharmacies would no longer be permitted to compound these GLP-1 drugs in bulk.

Stealth BioTherapeutics deployed the Forzinity (elamipretide/SS-31) commercial field team in April 2026 and full sales operations in early May 2026 for the FDA-approved Barth syndrome indication (accelerated approval September 2025). A mid-April 2026 FDA meeting also discussed a regulatory pathway for POLG-related mitochondrial myopathy, with a pivotal trial synopsis submission planned for H2 2026.

FDA proposes to end 503B outsourcing-facility compounding of semaglutide, tirzepatide, and liraglutide

On April 30, 2026, the FDA published a proposed rule (Federal Register 2026-08552) to formally exclude semaglutide, tirzepatide, and liraglutide from the 503B outsourcing-facility bulk drug substances list. If finalized, outsourcing-facility compounding pharmacies would be prohibited from producing these GLP-1 agonists. This is a proposed rule — public comment period runs through June 29, 2026; no final rule has been published.

FDA proposes excluding semaglutide, tirzepatide, and liraglutide from 503B outsourcing bulks list

The FDA published a proposed rule concluding there is no clinical need for 503B outsourcing facilities to compound semaglutide, tirzepatide, or liraglutide from bulk substances. A comment period ran through June 29, 2026. If finalized, this would end large-scale compounded GLP-1 production by 503B outsourcing facilities; the 503A individual-patient compounding pathway is governed separately.

The FDA approved Langlara (insulin glargine-aldy, 100 units/mL) on April 29, 2026 as the third interchangeable biosimilar to Lantus in the US, and the first from a Chinese manufacturer (Sunshine Lake Pharma / Lanexa Biologics / Lannett Company). Interchangeable status allows pharmacist substitution without prescriber authorization, subject to state law. Indicated for type 1 diabetes (adults and pediatric patients) and type 2 diabetes in adults.

Boehringer Ingelheim released positive topline results from SYNCHRONIZE-1 (725 adults with obesity, no T2D, 76 weeks). Survodutide achieved 16.6% mean body weight reduction vs 3.2% for placebo, with 85.1% of participants losing at least 5% of body weight. Full data will be presented at ADA 2026 Scientific Sessions. The US NDA was submitted in February 2026.

A comprehensive structure-activity relationship (SAR) analysis of the SLU-PP-332 scaffold was published April 28, 2026 in the International Journal of Biological Macromolecules (PMID 41850449). The study identified analogs with improved ligand efficiency, aqueous solubility, or metabolic stability compared to the parent compound, establishing a design roadmap for next-generation exercise-mimetic therapeutics. SLU-PP-332 remains preclinical with no human trials.

On April 28, 2026, Protagonist Therapeutics elected to opt out of the US profit-and-loss sharing arrangement with Takeda for rusfertide, receiving an immediate $200 million payment. Takeda retains full US commercialization rights; Protagonist receives an additional $200 million upon FDA approval, a $75 million milestone, and tiered worldwide royalties of 14-29%. Rusfertide remains under FDA Priority Review for polycythemia vera with a PDUFA target date in Q3 2026.

Clinuvel Pharmaceuticals received final EMA scientific advice on April 24, 2026 endorsing the design of the pivotal CUV107 Phase 3 vitiligo study (n=300, primary endpoint T-VASI50, focus on Fitzpatrick skin types IV-VI). Enrollment is planned to start in H2 2026. A separate Phase 3 CUV105 vitiligo study remains active, with topline results expected H2 2026. This is for a new indication beyond the FDA-approved EPP indication.

The first generic desmopressin acetate (DDAVP) began marketing in the US on April 23, 2026, establishing generic competition for the branded product. Caplin Steriles also received FDA approval for a generic desmopressin acetate injection formulation at the same time.

PCAC July 23-24 full agenda confirmed: 7 peptides for July vote, 4 more in second batch before February 2027

Following the April 22, 2026 formal effective date of the Category 2 removals, the FDA's updated 503A bulk list and advisory committee calendar confirm the full PCAC schedule. Day 1 (July 23): BPC-157, TB-500, KPV, and MOTS-c. Day 2 (July 24): DSIP, Semax, and Epitalon. A second batch - GHK-Cu (injectable), LL-37, Melanotan II, and Dihexa - is scheduled for a separate PCAC meeting before February 2027. All listed peptides remain uncompoundable under current enforcement policy until PCAC vote and completed rulemaking.

FDA removes 12 peptides from Category 2 do-not-compound list

Effective April 22, 2026, the FDA removed 12 peptides from its Interim Category 2 'do not compound' list following withdrawal of the nominating safety concerns. Removal does not authorize compounding - it only lifts the explicit prohibition. Seven of the 12 (BPC-157, TB-500, MOTS-c, KPV, DSIP, Semax, Epitalon) proceeded to the July 23-24, 2026 PCAC meeting; the remaining five (GHK-Cu injectable, Melanotan II, LL-37, Dihexa, PEG-MGF) are scheduled for a second-wave PCAC review before February 2027.

FDA formally removes 12 peptides from 503A Category 2 effective April 22; BPC-157, TB-500, MOTS-c, LL-37, and Dihexa among those cleared of restriction

Effective April 22, 2026, the FDA formally removed 12 peptides from the 503A Category 2 (significant safety concern) list after nominators withdrew their designations. Full list: BPC-157, TB-500, MOTS-c, KPV, LL-37, Dihexa, Semax, DSIP, Epitalon, GHK-Cu (injectable route only), PEG-MGF, and Melanotan II. Removal from Category 2 lifts the explicit prohibition but does not grant compounding authority - formal 503A listing requires a positive PCAC recommendation and subsequent rulemaking. The FDA also announced a second PCAC meeting before February 2027 to review LL-37, Dihexa, GHK-Cu (injectable), and Melanotan II. Note: Melanotan II's removal from Category 2 does not change its exclusion from the reclassification pathway toward legal compounding.

In April 2026, the FDA issued an import alert on Pharmathen International's Rodopi, Greece facility - the exclusive contract manufacturer for Cipla's US lanreotide injection. Under the import alert, US Customs can detain Pharmathen shipments at the border without inspection. This escalates the Class II recall of March 13, 2026. Analysts project resupply is unlikely before March 2027, with an estimated $90-100 million in Cipla US revenue at risk. Ipsen's branded Somatuline Depot uses a separate supply chain and is unaffected.

Full SURPASS-CVOT cardiovascular outcomes data published in the New England Journal of Medicine (NEJMoa2505928). In 13,000+ T2D patients over ~4.5 years, tirzepatide was non-inferior to dulaglutide for MACE-3 (HR 0.92, 95% CI 0.84-1.01) and reduced all-cause mortality by 16% vs dulaglutide.

Peptide database now covers 107 peptides

The peptibase database has grown to 107 peptides across healing, weight loss, growth hormone, cognitive, anti-aging, immune, sexual health, skin/hair, hormonal, and bioregulator categories.

CagriSema REDEFINE 1 and 2 Phase 3 full datasets published in NEJM

Full Phase 3 data for REDEFINE 1 (22.7% weight loss at 68 weeks, vs 15.8% for semaglutide alone) and REDEFINE 2 were published in the New England Journal of Medicine. The CagriSema NDA remains under active FDA review with a decision expected Q4 2026.

Federal Register: FDA PCAC meeting scheduled July 23-24, 2026

The FDA posted a Federal Register notice scheduling the Pharmacy Compounding Advisory Committee (PCAC) meeting for July 23-24, 2026. The agenda includes formal review of Semax, DSIP (listed as Emideltide), and Epithalon for 503A Bulks List inclusion. This is the next procedural step before any peptide can legally return to Category 1 compounding.

Lilly announced positive ACHIEVE-4 Phase 3 results for Foundayo (orforglipron): the trial showed non-inferiority to insulin glargine for MACE-4 cardiovascular events and no drug-induced liver injury signal, directly addressing both post-approval safety data requirements set by FDA at the time of Foundayo's April 1, 2026 approval.

Melanotan II and Follistatin-344 explicitly excluded from reclassification

The HHS April 15 announcement explicitly excluded Melanotan II and Follistatin-344 from the peptides being moved back to Category 1. Both remain restricted under FDA Category 2, citing melanoma/cardiovascular concerns (Melanotan II) and insufficient safety data (Follistatin-344). No pathway to legal compounding at this time.

HHS announces 12 peptides moving from Category 2 back to Category 1

HHS Secretary RFK Jr. announced that 12 previously restricted peptides will be removed from FDA Category 2 and returned to Category 1 (legal compounding). This is an announcement of intent - formal FDA rulemaking is pending the July 23-24 PCAC review. As of today, all affected peptides remain Category 2 under current law. Affected peptides include Selank, Semax, DSIP, Epithalon, Thymosin Alpha-1, KPV, BPC-157, TB-500, Thymosin Beta-4, CJC-1295, and Ipamorelin.

The FDA granted Apotex Corp the first tentative Abbreviated New Drug Application (ANDA) approval for a generic semaglutide injection. Final approval is pending patent expiry, but this clears the regulatory path for generic competition on Ozempic in the US.

Novo Nordisk's higher-dose semaglutide (7.2mg weekly injection) was approved under the FDA's new National Priority Voucher accelerated review. The STEP UP trial showed 18.7% mean weight loss vs 3.9% placebo at 72 weeks. New dysesthesia safety signal at 22.9% at the 7.2mg dose - FDA is investigating.

April 2026 audit: 35 peptides updated with latest clinical data

Completed a platform-wide audit refreshing clinical status, side effects, dosing notes, and references for 35 peptides based on 2025-2026 research and regulatory changes.

The FDA approved Wegovy (semaglutide 2.4mg) for non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate-to-advanced fibrosis. This is the first GLP-1 receptor agonist approved for MASH treatment.

Added Rusfertide, a hepcidin mimetic in late-stage trials for polycythemia vera. Full profile with mechanism, clinical status, side effects, and references.

The FDA approved orforglipron under the brand name Foundayo on April 1, 2026 via the Commissioner's National Priority Voucher program (50-day review). First daily oral GLP-1 pill for weight loss. FDA has since requested additional post-approval safety data from Lilly. Distribution began April 6.

The European Medicines Agency's CHMP issued a positive opinion recommending authorization of Imcivree (setmelanotide) for acquired hypothalamic obesity, a week after the FDA approval. EU approval is now expected.

The FDA approved Awiqli (insulin icodec-abae) on March 26, 2026 - the first and only once-weekly basal insulin for adults with type 2 diabetes. Based on the ONWARDS Phase 3 trial program. Not approved for type 1 diabetes due to hypoglycemia concerns.

On March 19, 2026, the FDA approved Imcivree (setmelanotide) for acquired hypothalamic obesity - a first-in-class approval based on the Phase 3 TRANSCEND trial showing 18.4% placebo-adjusted BMI reduction.

Eli Lilly reported TRANSCEND-T2D-1 Phase 3 data for retatrutide in type 2 diabetes. HbA1c dropped 1.7-2.0% across doses vs 0.8% placebo at 40 weeks; 36.6 lb (16.8%) weight loss at the 12mg dose. This is the second public Phase 3 readout after TRIUMPH-4 (Dec 2025).

The FDA approved a ready-to-use 3-month injectable leuprolide mesylate depot for advanced prostate cancer, with a 97.9% castrate testosterone rate in the Phase 3 trial. Extends dosing interval for patients on androgen deprivation therapy.

FDA recalls CJC-1295 injectable due to sterility concerns

The FDA recalled CJC-1295 injectable products due to sterility concerns. Users should discontinue affected lots and consult a healthcare provider. This is a separate enforcement action from the broader peptide reclassification review.

Cipla recalled multiple US batches of lanreotide injection in March 2026 after the FDA classified supplier Pharmathen's Greek facility with an Official Action Indicated (OAI) inspection outcome. Supply disruption is expected through fiscal year 2027.

Added SUMMIT trial data showing a 38% reduction in cardiovascular death or heart failure events in patients with HFpEF. Added to EU labeling in January 2026.

Updated Tesamorelin profile to reflect the March 2025 FDA approval of the new F8 formulation (Egrifta WR), which moves from daily to weekly reconstitution at a 1.28mg dose. Added CROI 2025 data on BMI limitations for cardiovascular risk.

Added Phase 2 trial data for Thymosin Beta-4 (73-patient venous stasis ulcer trial, dry eye trials), a metastasis/cancer concern noted in the literature, and WADA prohibited status.

Selank was removed from FDA Category 2 in September 2024 and is now scheduled for PCAC review - a positive signal for compounding availability.

Added dysesthesia (~21% incidence at the highest dose) to Retatrutide's side effect profile based on TRIUMPH-4 trial data.

Added a 2024 observational study in 21 men. Phase II/III male trials are planned for 2025.

Updated Orforglipron FDA decision date (delayed from March to April 10, 2026) and added LillyDirect pricing information ($149-$399/month).

Updated MK-677 profile to reflect December 2025 FDA warning letter enforcement. Added bone mineral density effects, muscle/joint pain, and numbness to the side effect profile.

Promoted GHK-Cu from evidence level 4 to level 2 based on new human data: a 2023 split-face study showing 22% firmness increase and 16% fine line reduction, a 2024 laser resurfacing study (25% faster healing), and 2025 ulcerative colitis research.

Added the 2025 American Journal of Sports Medicine systematic review that screened 544 articles and found only one clinical study met inclusion criteria. Highlights the lack of pharmaceutical interest due to BPC-157's non-patentability.

The FDA initiated a recall of 665 bottles of iKids-Growth Day Formula and Night Formula after finding undeclared ibutamoren (MK-677) in children's height and growth supplements. Part of ongoing FDA enforcement against unapproved MK-677 in consumer products.

Added PE-22-28, an investigational peptide being researched for depression and anxiety via modulation of TREK-1 channels.

A 2026 analysis strengthens the cardiovascular safety profile of abaloparatide in postmenopausal women with osteoporosis, showing similar serious CV event rates (0.9-1.0%) across treatment and placebo groups.

COSCIENS Biopharma (formerly Aeterna Zentaris) announced on March 5, 2026 that it is surrendering commercial rights to Macrilen (macimorelin) as its German subsidiaries enter insolvency proceedings. The biopharmaceutical business, including Macrilen rights, was reclassified as discontinued operations effective March 27, 2026. Macrilen remains FDA-approved for AGHD diagnosis, but supply continuity and commercial availability may be disrupted.

The FDA accepted Takeda's New Drug Application for rusfertide in polycythemia vera and granted Priority Review. The PDUFA target action date is Q3 2026. Rusfertide is a first-in-class hepcidin mimetic.

Tonix announced a 2026 Phase 2 trial of intranasal oxytocin (TNX-2900) in children and adolescents with Prader-Willi syndrome hyperphagia. First Phase 2 study targeting the unmet need for PWS appetite control.

A 2026 disproportionality analysis of the FDA Adverse Event Reporting System confirmed known risks (bleeding, intracranial hemorrhage, stroke, thrombocytopenia, hypotension) for off-label eptifibatide use in acute respiratory distress syndrome.

Full manual database review completed

Completed a full manual review of all peptides, focused on community doses, scientific citations, side effects, and regulatory status.

The FDA approved ET-600 (Desmoda), the first oral liquid desmopressin formulation for pediatric and adult central diabetes insipidus. Distribution began March 9, 2026. Offers a dosing alternative for pediatric patients who struggle with tablets.

Following the initial generic liraglutide approvals, additional generic Saxenda (liraglutide 3.0mg for weight management) competitors are expected to enter the US market after February 24, 2026, further expanding pricing options.

CagriSema: REDEFINE 4 misses non-inferiority vs tirzepatide

Novo Nordisk announced that CagriSema 2.4/2.4mg failed to meet the non-inferiority endpoint vs tirzepatide 15mg in the REDEFINE 4 trial, despite delivering 23% weight loss. The failure complicates CagriSema's regulatory path and competitive positioning.

Boehringer Ingelheim submitted the US New Drug Application for survodutide (GLP-1/glucagon dual agonist) in February 2026. Based on SYNCHRONIZE Phase 3 data showing 15.7% weight loss and 62.9% MASH resolution at 48 weeks.

UK MHRA safety update: rare severe pancreatitis with GLP-1 class

The UK MHRA updated product labels for GLP-1 receptor agonists and dual GIP/GLP-1 agonists in early 2026 regarding rare severe and necrotizing pancreatitis, based on 1,296 Yellow Card reports (19 fatal, 24 necrotizing). Applies to the entire GLP-1 class.

The FDA accepted Camurus's resubmitted New Drug Application for Oclaiz (CAM2029), a long-acting octreotide depot for acromegaly. PDUFA target date is June 10, 2026.

The FDA approved the Ozempic brand name for 1.5mg, 4mg, and 9mg oral semaglutide tablets (type 2 diabetes) with improved bioavailability vs the original Rybelsus formulation. Commercial launch expected Q2 2026.

Mylan Pharmaceuticals received FDA approval for generic linaclotide capsules at 145 mcg and 290 mcg doses, providing a lower-cost option for IBS-C and chronic idiopathic constipation.

4 new Khavinson bioregulators added

Expanded the bioregulator category with Thymogen, Vesilute, Pancragen, and Normoftal - short peptides developed at the Saint Petersburg Institute of Bioregulation and Gerontology.

100-peptide milestone reached

Added Bronchogen and PNC27 to cross the 100-peptide mark. Bronchogen is a respiratory bioregulator; PNC27 is a p53-derived oncolytic peptide under preclinical study.

Stealth BioTherapeutics' full New Drug Application for elamipretide (SS-31) has a PDUFA target date of September 2026 pending biomarker validation. A 30-patient Phase 2 trial in Barth syndrome was initiated in February 2026, evaluating LVEF and neutrophil endpoints at 12 and 24 weeks.

Added FOXO4-DRI, a senolytic peptide that selectively induces apoptosis in senescent cells. Added by community request with full dosing protocols.

New peptides added: Cagrilintide and Glutathione

Added Cagrilintide, a long-acting amylin analog under review in the CagriSema combination, and Glutathione, a widely used antioxidant peptide.

New peptides added: 5-Amino-1MQ and KPV

Added 5-Amino-1MQ (a NNMT inhibitor researched for metabolic health) and KPV (an anti-inflammatory tripeptide). Also launched the peptide Stack Builder.

11 Khavinson bioregulators added

Major expansion of the bioregulator category: added Livagen, Ovagen, Cortagen, Vesugen, Chonluten, Crystagen, Prostamax, Testagen, Thyreogen, Ventfort, and Veslugen.

Added ARA-290, an erythropoietin-derived peptide under investigation for small fiber neuropathy, sarcoidosis, and diabetic pain.

New peptides added: GB-115 and Thymosin Beta-4

Added GB-115 (an anxiolytic tripeptide from the Russian research program) and Thymosin Beta-4 as a distinct entry, clarifying its relationship to the TB-500 fragment.

peptibase launched with 76 peptides

Initial public launch of the peptibase research database covering 76 peptides across healing, GLP-1 agonists, growth hormone, cognitive, sexual health, skin, and bioregulator categories - each with mechanism, research summary, dosing, and references.