Pemetrexed Disodium: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Pemetrexed Disodium appears in the FDA drug-label database. Marketed as Pemetrexed.
FDA-approved use
Pemetrexed for injection is a folate analog metabolic inhibitor indicated: in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. ( 1.1 ) in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC. ( 1.1 ) as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. ( 1.1 ) as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. ( 1.1 ) Limitations of Use: Pemetrexed for injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer. ( 1.1 ) initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery. ( 1.2 ) 1.1 Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Pemetrexed for Injection is indi…
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials — Shilpa Medicare Limited | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2026-07-29 |
| Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials — Shilpa Medicare Limited | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2026-07-29 |
Phase breakdown
Conditions being studied
Recruiting trials involving Pemetrexed Disodium
- A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors
- Perioperative Tislelizumab for Resectable II-IIIB(N2) KRAS-mutated Nonsquamous Non-small Cell Lung Cancer
- Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, an ALCHEMIST Treatment Trial (Chemo-IO [ACCIO])
Common questions
Is Pemetrexed Disodium FDA-approved?
Yes, marketed as Pemetrexed.
How many recruiting trials involve Pemetrexed Disodium?
3 recruiting trials across 11 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.