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nedaplatin+pemetrexed
nedaplatin+pemetrexed is a Platinum-based chemotherapy, Antifolate Small molecule drug developed by Sun Yat-sen University. It is currently in Phase 3 development for Non-small cell lung cancer, Ovarian cancer.
Nedaplatin is a platinum-based chemotherapy drug that works by crosslinking DNA, thereby inhibiting DNA replication and transcription, while pemetrexed is an antifolate drug that inhibits thymidylate synthase, dihydrofolate reductase, and glycinamide ribonucleotide formyltransferase, leading to DNA synthesis inhibition.
Nedaplatin is a platinum-based chemotherapy drug that works by crosslinking DNA, thereby inhibiting DNA replication and transcription, while pemetrexed is an antifolate drug that inhibits thymidylate synthase, dihydrofolate reductase, and glycinamide ribonucleotide formyltransferase, leading to DNA synthesis inhibition. Used for Non-small cell lung cancer, Ovarian 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 | nedaplatin+pemetrexed |
|---|---|
| Sponsor | Sun Yat-sen University |
| Drug class | Platinum-based chemotherapy, Antifolate |
| Target | DNA, Thymidylate synthase, Dihydrofolate reductase, Glycinamide ribonucleotide formyltransferase |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Nedaplatin's mechanism involves the formation of platinum-DNA adducts, which interfere with DNA replication and transcription, ultimately leading to cell death. Pemetrexed, on the other hand, inhibits key enzymes involved in folate metabolism, resulting in the depletion of essential nucleotides required for DNA synthesis and cell proliferation.
Approved indications
- Non-small cell lung cancer
- Ovarian cancer
Common side effects
- Myelosuppression
- Nausea and vomiting
- Diarrhea
- Fatigue
- Anemia
Key clinical trials
- Pemetrexed/Platinum With or Without Bevacizumab in Brain Metastases From Patients With EGFR/ALK Negative Non-Squamous Non-small Cell Lung Cancer (PHASE3)
- A Study of Adebrelimab in Combination with Chemo with or Without Bevacizumab Neoadjuvant Therapy for Resectable NSCLC (PHASE2)
- A Study Comparing Neoadjuvant Chemoimmunotherapy and Immuno-consolidationafter Compared With Immunoconsolidation After Radical Chemoradiotherapy for Stage III Potentially Resectable NSCLC (PHASE2)
- Thalidomide Prevention or Treatment of Camrelizumab-induced Reactive Cutaneous Capillary Endothelial Proliferation (RCCEP) (PHASE2)
- First-Line Treatment for Advanced Non-squamous Non-Small-Cell Lung Cancer With Negative Driver Gene: a Single-center, Single-Arm Trial (PHASE3)
- Gefitinib With or Without Chemotherapy in Brain Metastases From Non-small Cell Lung Cancer (PHASE3)
- A Prospective Multi-center Phase III Randomized Controlled Trial (PHASE3)
- Curative Study of Chinese Traditional Medicine to Treat Lung Cancer (PHASE2, PHASE3)
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:
- nedaplatin+pemetrexed CI brief — competitive landscape report
- nedaplatin+pemetrexed updates RSS · CI watch RSS
- Sun Yat-sen University portfolio CI
Frequently asked questions about nedaplatin+pemetrexed
What is nedaplatin+pemetrexed?
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Related
- Drug class: All Platinum-based chemotherapy, Antifolate drugs
- Target: All drugs targeting DNA, Thymidylate synthase, Dihydrofolate reductase, Glycinamide ribonucleotide formyltransferase
- Manufacturer: Sun Yat-sen University — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Non-small cell lung cancer
- Indication: Drugs for Ovarian cancer
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing