FDA · United States
pemetrexed sodium — FDA regulatory status
pemetrexed sodium (PEMETREXED) 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
- PEMETREXED
- Originator
- Teva Pharma GmbH
- Mechanism
- Thymidylate synthase inhibitor
- Target
- Dihydrofolate reductase
- Structured fields
- 8
Sponsor / originator context: Teva Pharma GmbH. 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: Thymidylate synthase inhibitor. Target: Dihydrofolate reductase. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 116 published clinical programs and 4 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 |
|---|---|---|---|
| 22615 | Phase 3 | Bayer | 2024-511319-91-00 |
| 61186372NSC3001 | Phase 3 | Janssen-Cilag International N.V | 2023-506033-29-00 |
| 61186372NSC3002 | Phase 3 | Janssen-Cilag International N.V | 2023-506518-33-00 |
| APHP241011 | Phase 3 | PARItec | 2025-521891-78-00 |
| Abraxane /ml powder for dispersion for infusion. for metastatic NSCLC patients | Phase 3 | Telethon Foundation | 2025-522084-15-00 |
| BNT327-06 | Phase 3 | BioNTech SE | 2024-515764-31-00 |
| BO42864 | Phase 3 | HOFFMANN-LA ROCHE | 2023-505035-12-00 |
| C6461001 | Phase 3 | First Biotech (Australia) | 2025-523461-17-01 |
| CA2241093 | Phase 3 | Bristol-Myers Squibb Australia | 2024-513682-40-01 |
| CA239-0004 | Phase 3 | Bristol-Myers Squibb Australia | 2024-515698-85-00 |
| CA240-0029 | Phase 3 | Bristol-Myers Squibb Australia | 2025-521511-40-00 |
| CA244-0010 | Phase 3 | Bristol-Myers Squibb Australia | 2025-521908-22-00 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 11612662 | Multi-arm polymeric prodrug conjugates of pemetrexed-based compounds | US |
| 10736969 | Multi-arm polymeric prodrug conjugates of pemetrexed-based compounds | US |
| 2882753 | VERFAHREN ZUR HERSTELLUNG VON PEMETREXED UND EINEM LYSINSALZ DAVON | EP |
| 8952153 | One pot process for preparing pemetrexed disodium | US |
Related hubs
FAQ
What is the FDA approval status of pemetrexed sodium?
pemetrexed sodium 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 pemetrexed sodium 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 pemetrexed sodium?
This spoke lists 116 published programs associated with pemetrexed sodium in our pipeline index.