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Short updates on new peptide drugs and rule changes, newest first. Each one links to the official source. "Proposed" means not final. For learning only, not medical advice.

What's new

Proposed, not final

HHS proposes letting pharmacies custom-mix six peptides (not final)

HHS's draft enforcement discretion policy covers 503A compounding of BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500 under strict conditions. It is a draft open for comment, not FDA approval, and it is not binding. Comments are accepted for two weeks after publication, so they close about Nov 13, 2026 (check the docket for the exact time).

Sources: Federal Register 2026-22192 · HHS policy PDF · Docket HHS-OASH-2026-0496

Read our explainer →

Regulatory

Last day to comment on the HHS proposal (about Nov 13)

Source: Federal Register 2026-22192

Under FDA review

CagriSema (cagrilintide + semaglutide), Novo Nordisk

Novo Nordisk submitted a New Drug Application to the FDA on Dec 18, 2025 for weight management, and said the FDA was expected to review it in 2026. CagriSema is not approved in the US or EU.

Source: Novo Nordisk, Dec 18, 2025

Phase 3

Amycretin, Novo Nordisk

Novo Nordisk said in June 2025 it would move injectable and oral amycretin, a single molecule acting on GLP-1 and amylin receptors, into phase 3 for weight management. It is investigational.

Source: Novo Nordisk announcement, Jun 12, 2025 (SEC filing)

Phase 3

MariTide (maridebart cafraglutide), Amgen

Amgen's phase 3 MARITIME program studies MariTide, an antibody-peptide conjugate, in obesity (MARITIME-1) and type 2 diabetes with obesity (MARITIME-2), with further studies in heart disease, heart failure and sleep apnea. It is investigational.

Sources: Amgen: Inside MARITIME · Amgen: The story of MariTide (May 2026)

FDA-approved

Orforglipron (Foundayo), Eli Lilly

The FDA approved Foundayo (orforglipron), a once-daily oral GLP-1 receptor agonist, for chronic weight management in adults with obesity, or overweight with a weight-related condition. Note: orforglipron is a small molecule, not a peptide; we track it because it competes with peptide GLP-1 medicines.

Sources: FDA press announcement, Apr 1, 2026 · FDA approval letter, NDA 220934

What the labels mean

  • Lab research only: not approved for people.
  • In human trials: being tested in people. Not approved.
  • HHS proposal: a draft rule open for public comment. Not final. Not FDA approval.
  • FDA-approved: the FDA approved it for a specific use.

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Last checked Oct 30, 2026. The PeptideX team.