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oxaliplatin;s1
oxaliplatin;s1 is a Platinum-based chemotherapy Small molecule drug developed by Chinese Academy of Medical Sciences. It is currently in Phase 3 development for Treatment of metastatic colorectal cancer, Treatment of advanced gastric cancer.
Oxaliplatin is a platinum-based chemotherapy drug that works by crosslinking DNA, thereby inhibiting DNA replication and transcription.
Oxaliplatin is a small molecule DNA inhibitor used in cancer treatment. It has been studied in clinical trials for various conditions, including gastric cancer, esophageal cancer, and 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 | oxaliplatin;s1 |
|---|---|
| Sponsor | Chinese Academy of Medical Sciences |
| Drug class | Platinum-based chemotherapy |
| Target | DNA |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
This process ultimately leads to cell death, making it effective against rapidly dividing cancer cells. Oxaliplatin is a type of alkylating agent that targets the DNA repair mechanism, causing DNA damage and triggering apoptosis.
Approved indications
- Treatment of metastatic colorectal cancer
- Treatment of advanced gastric cancer
Common side effects
- Neurotoxicity
- Myelosuppression
- Diarrhea
- Nausea and vomiting
Key clinical trials
- HAIC Plus Systemic Therapy as De-escalation Therapy Strategy for Biliary Tract Cancer (NA)
- Durvalumab With Chemotherapy as First Line Treatment in Patients With Advanced Biliary Tract Cancers (aBTCs) (PHASE3)
- A Clinical Study of Sintilimab Combined With Chemothrapy Versus Chemotherapy as Adjuvant Therapy for Gastric/Gastroesophageal Junction Adenocarcinoma (PHASE2)
- Oxaliplatin Combined With Irinotecan Liposome Injection II Through Hepatic Artery Infusion (HAIC) Followed by 5-FU/LV (HAIC) or Tegorgor Oral Combination Therapy for Hepatic Metastasis of Pancreatic Cancer (PHASE2)
- IBI343 in Combination With Sintilimab and SOX Regimen for Perioperative Treatment of Resectable, Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (PHASE2)
- Disitamab Vedotin Combined With SOX Regimen Versus SOX Alone as Adjuvant Therapy for HER2-Moderate/High Expressing Stage Ⅲ Gastric Cancer: A Prospective, Multicenter, Randomized, Phase Ⅱ Clinical Trial (PHASE2)
- A Study to Investigate the Efficacy and Safety of ONO-4578 in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer) (PHASE2)
- SHR-1701 With or Without Apatinib in Combination With Chemotherapy as Neoadjuvant Therapy for Gastric Cancer (PHASE2)
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:
- oxaliplatin;s1 CI brief — competitive landscape report
- oxaliplatin;s1 updates RSS · CI watch RSS
- Chinese Academy of Medical Sciences portfolio CI
Frequently asked questions about oxaliplatin;s1
What is oxaliplatin;s1?
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What is oxaliplatin;s1 used for?
Who makes oxaliplatin;s1?
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What development phase is oxaliplatin;s1 in?
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Related
- Drug class: All Platinum-based chemotherapy drugs
- Target: All drugs targeting DNA
- Manufacturer: Chinese Academy of Medical Sciences — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Treatment of metastatic colorectal cancer
- Indication: Drugs for Treatment of advanced gastric cancer
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing