FDA · United States
medroxyprogesterone acetate — FDA regulatory status
medroxyprogesterone acetate (MEDROXYPROGESTERONE ACETATE) regulatory status in the United States is tracked from public FDA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: FDA approved.
Status snapshot
- Status
- FDA approved
- Brand
- MEDROXYPROGESTERONE ACETATE
- Originator
- Amneal Pharma Europe Ltd
- Mechanism
- Progesterone receptor agonist
- Target
- Progesterone receptor
- Structured fields
- 8
Sponsor / originator context: Amneal Pharma Europe Ltd. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: Progesterone receptor agonist. Target: Progesterone receptor. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 18 published clinical programs and 12 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| FDA | United States | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| FLECAINIDE | Phase 3 | PARItec | 2024-513324-42-00 |
| Normal Saline | Phase 3 | First People's Hospital | NCT06281561 |
| Progesterone | Phase 3 | TherapeuticsMD | NCT02019589 |
| ASPIRE | Phase 2 | George Institute for | 2025-521459-22-00 |
| DR-2021a | Phase 2 | Teva Pharma | NCT00196391 |
| Liposuction | Phase 2 | First People's Hospital | NCT02469792 |
| Mibavademab | Phase 2 | Regeneron UK | NCT07235917 |
| PBGENE-DMD (IV) | Phase 2 | Chongqing Precision Biotech | NCT07429240 |
| Provox Vega voice prosthesis 22.5 Fr | Phase 2 | ATOSSA THERAPEUTICS | NCT00884910 |
| Tranexamic Acid | Phase 2 | United Therapeutics Europe | NCT03552705 |
| Vodobatinib (K0706) capsules | Phase 2 | Advanced Accelerator Applications | NCT02629692 |
| ENZAL-15-24 | Phase 1 | Anaxis Pharma | 2024-518209-16-00 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 2026115454 | ANTICORPS ANTI-CLAUDINE 18.2, FRAGMENTS DE LIAISON À L'ANTIGÈNE ET CONJUGUÉS ANTICORPS-MÉDICAMENT ASSOCIÉS ET MÉTHODES D'UTILISATION DANS UNE THÉRAPIE ANTICANCÉREUSE | WO |
| 2026107136 | CONJUGUÉS ANTICORPS ANTI-CEACAM5-MÉDICAMENT POUR LE TRAITEMENT DU CANCER | WO |
| 2026052764 | PROCÉDÉ DE NOTATION POUR UNE THÉRAPIE PAR CONJUGUÉ ANTICORPS ANTI-TROP2-MÉDICAMENT | WO |
| 2026042803 | UTILISATION D'UN ANTICORPS BISPÉCIFIQUE ANTI-CLDN4/ANTI-CD137 EN COMBINAISON AVEC UN MÉDICAMENT À BASE DE PLATINE POUR LE TRAITEMENT DU CANCER | WO |
| 2025260285 | CONJUGUÉ ANTICORPS-MÉDICAMENT | WO |
| 2025262130 | CONJUGUÉ ANTICORPS-MÉDICAMENT | WO |
| 2025250831 | CONJUGUÉS ANTICORPS-MÉDICAMENT IMMUNOSTIMULANTS À BASE D'AGONISTE DE STING | WO |
| 12403167 | Phenylethanoid glycoside extract from Acanthus ilicifolius L., preparation method thereof and use as anti-liver injury medicament | US |
| 4541380 | STABILE KONZENTRIERTE RADIONUKLID-KOMPLEX-LÖSUNGEN | EP |
| 2024249235 | CONJUGUÉS ANTICORPS-MÉDICAMENT D'AGENT DE DÉGRADATION DE BET ANTI-CD33 HUMAIN | WO |
| 2024243450 | MÉTHODES DE TRAITEMENT UTILISANT DES CONJUGUÉS ANTICORPS-MÉDICAMENT ANTI-C-MET | WO |
| 2024223388 | COMPLEXES CRISTALLINS ENTRE LA VELAGLIFLOZINE ET DES AGENTS DE FORMATION DE CO-CRISTAUX SÉLECTIONNÉS, LEURS PROCÉDÉS DE PRÉPARATION ET LEUR UTILISATION POUR LA PRÉPARATION DE MÉDICAMENTS | WO |
Related hubs
FAQ
What is the FDA approval status of medroxyprogesterone acetate?
medroxyprogesterone acetate currently shows FDA approved in our United States regulatory index. Confirm on the official FDA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get medroxyprogesterone acetate regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to medroxyprogesterone acetate?
This spoke lists 18 published programs associated with medroxyprogesterone acetate in our pipeline index.