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Pemetrexed Disodium Injection
Pemetrexed Disodium Injection is a Antifolate antimetabolite Small molecule drug developed by Shanghai Miracogen Inc.. It is currently in Phase 3 development for Non-small cell lung cancer (NSCLC), Mesothelioma, Colorectal cancer. Also known as: Alimta.
Pemetrexed is a folate antagonist that inhibits multiple enzymes involved in nucleotide synthesis, disrupting DNA and RNA production in cancer cells.
Pemetrexed is a folate antagonist that inhibits multiple enzymes involved in nucleotide synthesis, disrupting DNA and RNA production in cancer cells. Used for Non-small cell lung cancer (NSCLC), Mesothelioma, Colorectal cancer.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Pemetrexed Disodium Injection |
|---|---|
| Also known as | Alimta |
| Sponsor | Shanghai Miracogen Inc. |
| Drug class | Antifolate antimetabolite |
| Target | Thymidylate synthase, dihydrofolate reductase, glycinamide ribonucleotide formyltransferase |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Pemetrexed disodium is a multitargeted antifolate that inhibits thymidylate synthase, dihydrofolate reductase, and glycinamide ribonucleotide formyltransferase, key enzymes in the folate pathway required for purine and pyrimidine synthesis. By blocking these enzymes, it prevents DNA and RNA synthesis, leading to cell cycle arrest and apoptosis in rapidly dividing cancer cells. It is typically administered with folic acid and vitamin B12 supplementation to reduce toxicity to normal tissues.
Approved indications
- Non-small cell lung cancer (NSCLC)
- Mesothelioma
- Colorectal cancer
Common side effects
- Myelosuppression (neutropenia, anemia, thrombocytopenia)
- Nausea and vomiting
- Mucositis
- Fatigue
- Diarrhea
- Elevated liver enzymes
Key clinical trials
- A Study to Evaluate the Bioavailability of Pembrolizumab (MK-3475) Via Subcutaneous (SC) Injection of Pembrolizumab Formulated With Berahyaluronidase Alfa (MK-5180) [MK-3475A] In Advanced Solid Tumors (MK-3475A-C18) (PHASE1)
- Fulzerasib Sequential Sintilimab Plus Platinum-Doublet Neoadjuvant Therapy for Resectable KRAS G12C-Mutant NSCLC (PHASE2)
- A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009) (PHASE3)
- Phase III Study of AK112 for NSCLC Patients (PHASE3)
- A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007) (PHASE3)
- Comparing the Efficacy and Safety of a New Additional Treatment With Tislelizumab in Non-Small Cell Lung Cancer (NSCLC) (PHASE3)
- Pembrolizumab Plus Bevacizumab and Chemotherapy for Non-Squamous NSCLC Patients (PHASE2)
- A Phase Ib Study of RC148 as Monotherapy or Combination for Locally Advanced or Metastatic NSCLC (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Pemetrexed Disodium Injection CI brief — competitive landscape report
- Pemetrexed Disodium Injection updates RSS · CI watch RSS
- Shanghai Miracogen Inc. portfolio CI
Frequently asked questions about Pemetrexed Disodium Injection
What is Pemetrexed Disodium Injection?
How does Pemetrexed Disodium Injection work?
What is Pemetrexed Disodium Injection used for?
Who makes Pemetrexed Disodium Injection?
Is Pemetrexed Disodium Injection also known as anything else?
What drug class is Pemetrexed Disodium Injection in?
What development phase is Pemetrexed Disodium Injection in?
What are the side effects of Pemetrexed Disodium Injection?
What does Pemetrexed Disodium Injection target?
Related
- Drug class: All Antifolate antimetabolite drugs
- Target: All drugs targeting Thymidylate synthase, dihydrofolate reductase, glycinamide ribonucleotide formyltransferase
- Manufacturer: Shanghai Miracogen Inc. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Non-small cell lung cancer (NSCLC)
- Indication: Drugs for Mesothelioma
- Indication: Drugs for Colorectal cancer
- Also known as: Alimta
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing