Last reviewed 2026-04-23 · How we verify

Inj.Cisplatin

Tata Memorial Hospital · Phase 3 active Small molecule

Inj.Cisplatin is a Platinum-based alkylating agent Small molecule drug developed by Tata Memorial Hospital. It is currently in Phase 3 development for Metastatic testicular cancer, Metastatic ovarian cancer, Advanced bladder cancer.

Cisplatin is a platinum-based chemotherapy agent that forms DNA crosslinks, preventing DNA replication and transcription in cancer cells.

Cisplatin is a platinum-based chemotherapy agent that forms DNA crosslinks, preventing DNA replication and transcription in cancer cells. Used for Metastatic testicular cancer, Metastatic ovarian cancer, Advanced bladder cancer.

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 name	Inj.Cisplatin
Sponsor	Tata Memorial Hospital
Drug class	Platinum-based alkylating agent
Target	DNA
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

Cisplatin binds to DNA and forms intrastrand and interstrand crosslinks, which distort the DNA helix and block replication and transcription machinery. This leads to cell cycle arrest and apoptosis in rapidly dividing cancer cells. It is non-cell-cycle specific and effective against a broad range of malignancies.

Approved indications

Metastatic testicular cancer
Metastatic ovarian cancer
Advanced bladder cancer
Head and neck cancer
Non-small cell lung cancer
Small cell lung cancer

Common side effects

Nephrotoxicity
Ototoxicity
Nausea and vomiting
Myelosuppression (thrombocytopenia)
Myelosuppression (leukopenia)
Peripheral neuropathy
Anemia
Electrolyte abnormalities (hypomagnesemia)

Key clinical trials

Neoadjuvant Chemotherapy Followed by Surgery Versus Concurrent Chemoradiation in Carcinoma of the Cervix (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:

Inj.Cisplatin CI brief — competitive landscape report
Inj.Cisplatin updates RSS · CI watch RSS
Tata Memorial Hospital portfolio CI

Frequently asked questions about Inj.Cisplatin

What is Inj.Cisplatin?

Inj.Cisplatin is a Platinum-based alkylating agent drug developed by Tata Memorial Hospital, indicated for Metastatic testicular cancer, Metastatic ovarian cancer, Advanced bladder cancer.

How does Inj.Cisplatin work?

Cisplatin is a platinum-based chemotherapy agent that forms DNA crosslinks, preventing DNA replication and transcription in cancer cells.

What is Inj.Cisplatin used for?

Inj.Cisplatin is indicated for Metastatic testicular cancer, Metastatic ovarian cancer, Advanced bladder cancer, Head and neck cancer, Non-small cell lung cancer.

Who makes Inj.Cisplatin?

Inj.Cisplatin is developed by Tata Memorial Hospital (see full Tata Memorial Hospital pipeline at /company/tata-memorial-hospital).

What drug class is Inj.Cisplatin in?

Inj.Cisplatin belongs to the Platinum-based alkylating agent class. See all Platinum-based alkylating agent drugs at /class/platinum-based-alkylating-agent.

What development phase is Inj.Cisplatin in?

Inj.Cisplatin is in Phase 3.

What are the side effects of Inj.Cisplatin?

Common side effects of Inj.Cisplatin include Nephrotoxicity, Ototoxicity, Nausea and vomiting, Myelosuppression (thrombocytopenia), Myelosuppression (leukopenia), Peripheral neuropathy.

What does Inj.Cisplatin target?

Inj.Cisplatin targets DNA and is a Platinum-based alkylating agent.

Drug class: All Platinum-based alkylating agent drugs
Target: All drugs targeting DNA
Manufacturer: Tata Memorial Hospital — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Metastatic testicular cancer
Indication: Drugs for Metastatic ovarian cancer
Indication: Drugs for Advanced bladder cancer

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