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chemoradiotherapy Cisplatin

Shandong Cancer Hospital and Institute · Phase 3 active Small molecule ✓ Verified May 2026

chemoradiotherapy Cisplatin is a Platinum-based chemotherapy Small molecule drug developed by Shandong Cancer Hospital and Institute. It is currently in Phase 3 development for Non-small cell lung cancer, ovarian cancer, testicular cancer, bladder cancer, and other types of cancer, Head and neck cancer. Also known as: Cisplatin.

Cisplatin works by interfering with DNA replication, causing cell death in rapidly dividing cancer cells.

Cisplatin is a small molecule used in chemoradiotherapy, specifically in the treatment of locally advanced cervical carcinoma and gastric cancer. It is administered concurrently with radiotherapy and other chemotherapeutic agents, such as albumin-bound paclitaxel, as part of a treatment regimen.

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 namechemoradiotherapy Cisplatin
Also known asCisplatin
SponsorShandong Cancer Hospital and Institute
Drug classPlatinum-based chemotherapy
ModalitySmall molecule
Therapeutic areaOncology
PhasePhase 3

Mechanism of action

Cisplatin is a platinum-based chemotherapy drug that forms platinum-DNA adducts, which trigger DNA repair mechanisms and ultimately lead to cell death. This process is particularly effective in rapidly dividing cancer cells, making cisplatin an effective treatment for various types of cancer.

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 chemoradiotherapy Cisplatin

What is chemoradiotherapy Cisplatin?

chemoradiotherapy Cisplatin is a Platinum-based chemotherapy drug developed by Shandong Cancer Hospital and Institute, indicated for Non-small cell lung cancer, ovarian cancer, testicular cancer, bladder cancer, and other types of cancer, Head and neck cancer.

How does chemoradiotherapy Cisplatin work?

Cisplatin works by interfering with DNA replication, causing cell death in rapidly dividing cancer cells.

What is chemoradiotherapy Cisplatin used for?

chemoradiotherapy Cisplatin is indicated for Non-small cell lung cancer, ovarian cancer, testicular cancer, bladder cancer, and other types of cancer, Head and neck cancer.

Who makes chemoradiotherapy Cisplatin?

chemoradiotherapy Cisplatin is developed by Shandong Cancer Hospital and Institute (see full Shandong Cancer Hospital and Institute pipeline at /company/shandong-cancer-hospital-and-institute).

Is chemoradiotherapy Cisplatin also known as anything else?

chemoradiotherapy Cisplatin is also known as Cisplatin.

What drug class is chemoradiotherapy Cisplatin in?

chemoradiotherapy Cisplatin belongs to the Platinum-based chemotherapy class. See all Platinum-based chemotherapy drugs at /class/platinum-based-chemotherapy.

What development phase is chemoradiotherapy Cisplatin in?

chemoradiotherapy Cisplatin is in Phase 3.

What are the side effects of chemoradiotherapy Cisplatin?

Common side effects of chemoradiotherapy Cisplatin include Nausea and vomiting, Neutropenia, Anemia, Thrombocytopenia, Kidney damage.

Related

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