Peptide & GLP-1 FDA Action Tracker

Recent FDA actions affecting peptide and GLP-1 medications: approvals, withdrawals, and changes to compounding status. This is the area that shifts fastest, and where our data stays current. Each entry is verified against FDA records.

Last updated 2026-06-02. Informational only, not legal or medical advice. Compounding legality also varies by state and is changing; confirm current status with a licensed pharmacist.

• 2026-04-01 Approved
  Orforglipron

  FDA approved the first oral small-molecule GLP-1 receptor agonist for chronic weight management.

• 2026-02 NDA filed
  Survodutide

  New Drug Application submitted to the FDA for MASH/obesity; not approved as of mid-2026.

• 2025-12-22 Approved (new formulation)
  Semaglutide

  FDA approved oral semaglutide (Wegovy 25 mg) for chronic weight management.

• 2025-09-19 Approved (accelerated)
  Elamipretide

  FDA accelerated approval for Barth syndrome. Heart-failure and mitochondrial-myopathy indications were not approved after failed trials.

• 2025 NDA under review
  CagriSema

  New Drug Application submitted on the pivotal REDEFINE data; under FDA review.

• 2024-10 Withdrawn
  Exenatide

  Byetta and Bydureon BCise were discontinued from the US market.

• 2023 Compounding restricted
  BPC-157

  FDA placed BPC-157 in the 503A Category 2 (significant-safety-risk) bulk-substances group, restricting compounding.

• 2023-01-01 Withdrawn
  Lixisenatide

  Adlyxin was voluntarily withdrawn from the US market for commercial reasons.