Database Updates

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.

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.

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.

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.

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.

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.

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 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.

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.

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.

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.

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

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

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 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.

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.

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

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

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.

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.

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.

Full manual database review completed

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

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.

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.

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 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.