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Docetaxol

Fudan University · Phase 2 active Small molecule

Docetaxol is a Small molecule drug developed by Fudan University. It is currently in Phase 2 development for Carcinoma of breast, Malignant tumor of head and/or neck, Malignant tumor of prostate.

Likelihood of approval
13.3% vs 15.3% industry baseline
If approved by FDA: likely 2031–2034
Steps remaining: Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 2 → approval rate +15.3pp
    Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
  • Oncology Phase 2 attrition -2.0pp
    Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2031–2034
EMA EU 2032–2035 +0.7 yr
MHRA GB 2032–2035 +0.7 yr
Health Canada CA 2032–2036 +0.9 yr
TGA AU 2032–2036 +1.2 yr
PMDA JP 2032–2036 +1.5 yr
NMPA CN 2033–2037 +2.3 yr
MFDS KR 2032–2036 +1.4 yr
CDSCO IN 2032–2037 +1.8 yr
ANVISA BR 2033–2037 +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 nameDocetaxol
SponsorFudan University
TargetMultidrug resistance-associated protein 7, Multidrug resistance protein 1, Substance-K receptor
ModalitySmall molecule
Therapeutic areaOncology
PhasePhase 2

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 Docetaxol

What is Docetaxol?

Docetaxol is a Small molecule drug developed by Fudan University, indicated for Carcinoma of breast, Malignant tumor of head and/or neck, Malignant tumor of prostate.

What is Docetaxol used for?

Docetaxol is indicated for Carcinoma of breast, Malignant tumor of head and/or neck, Malignant tumor of prostate, Malignant tumor of stomach, Metastatic Breast Carcinoma.

Who makes Docetaxol?

Docetaxol is developed by Fudan University (see full Fudan University pipeline at /company/fudan-university).

What development phase is Docetaxol in?

Docetaxol is in Phase 2.

What are the side effects of Docetaxol?

Common side effects of Docetaxol include Neutropenia, Severe neutropenia, Febrile Neutropenia, Severe infectious episodes, Thrombocytopenia, Hypersensitivity Reactions.

What does Docetaxol target?

Docetaxol targets Multidrug resistance-associated protein 7, Multidrug resistance protein 1, Substance-K receptor.

Related

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