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SOX or CAPOX regimen

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Phase 3 active Small molecule ✓ Verified May 2026

SOX or CAPOX regimen is a Platinum-based chemotherapy Small molecule drug developed by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University. It is currently in Phase 3 development for Metastatic colorectal cancer.

Oxaliplatin and capecitabine work by interfering with DNA replication and repair, thereby inhibiting cancer cell growth.

The SOX regimen, which includes Pembrolizumab, is used to treat various types of cancer, including Gastric Neoplasms, Gastroesophageal Junction Adenocarcinoma, Esophageal Cancer, Gastric (Stomach) Cancer, and Gastric Adenocarcinoma. The regimen may also include Cisplatin, a chemotherapy medication, and is compared to a placebo in clinical trials.

Likelihood of approval
61.3% vs 58.3% industry baseline
If approved by FDA: likely 2028–2030
Steps remaining: NDA/BLA submission
Confidence: High
Why this estimate
  • 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.
Predicted approval windows by jurisdiction (conditional on FDA approval)
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 nameSOX or CAPOX regimen
SponsorDaping Hospital and the Research Institute of Surgery of the Third Military Medical University
Drug classPlatinum-based chemotherapy
ModalitySmall molecule
Therapeutic areaOncology
PhasePhase 3

Mechanism of action

Oxaliplatin is a platinum-based chemotherapy drug that forms platinum-DNA adducts, which interfere with DNA replication and repair. Capecitabine is a prodrug that is converted into 5-fluorouracil, which inhibits thymidylate synthase and disrupts DNA synthesis.

Approved indications

Common side effects

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about SOX or CAPOX regimen

What is SOX or CAPOX regimen?

SOX or CAPOX regimen is a Platinum-based chemotherapy drug developed by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, indicated for Metastatic colorectal cancer.

How does SOX or CAPOX regimen work?

Oxaliplatin and capecitabine work by interfering with DNA replication and repair, thereby inhibiting cancer cell growth.

What is SOX or CAPOX regimen used for?

SOX or CAPOX regimen is indicated for Metastatic colorectal cancer.

Who makes SOX or CAPOX regimen?

SOX or CAPOX regimen is developed by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University (see full Daping Hospital and the Research Institute of Surgery of the Third Military Medical University pipeline at /company/daping-hospital-and-the-research-institute-of-surgery-of-the-third-military-medi).

What drug class is SOX or CAPOX regimen in?

SOX or CAPOX regimen belongs to the Platinum-based chemotherapy class. See all Platinum-based chemotherapy drugs at /class/platinum-based-chemotherapy.

What development phase is SOX or CAPOX regimen in?

SOX or CAPOX regimen is in Phase 3.

What are the side effects of SOX or CAPOX regimen?

Common side effects of SOX or CAPOX regimen include Neutropenia, Diarrhea, Fatigue, Nausea, Vomiting.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing