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DHA-paclitaxel

Theradex · Phase 2 active Small molecule

DHA-paclitaxel is a Taxane Small molecule drug developed by Theradex. It is currently in Phase 2 development for Breast cancer, Ovarian cancer, Lung cancer.

Paclitaxel binds to tubulin, inhibiting microtubule formation and cell division.

Paclitaxel binds to tubulin, inhibiting microtubule formation and cell division. Used for Breast cancer, Ovarian cancer, Lung cancer.

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 nameDHA-paclitaxel
SponsorTheradex
Drug classTaxane
TargetBeta-tubulin
ModalitySmall molecule
Therapeutic areaOncology
PhasePhase 2

Mechanism of action

Paclitaxel stabilizes microtubules, preventing their disassembly and thereby inhibiting cell division. This leads to cell cycle arrest and apoptosis in rapidly dividing cancer cells.

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 DHA-paclitaxel

What is DHA-paclitaxel?

DHA-paclitaxel is a Taxane drug developed by Theradex, indicated for Breast cancer, Ovarian cancer, Lung cancer.

How does DHA-paclitaxel work?

Paclitaxel binds to tubulin, inhibiting microtubule formation and cell division.

What is DHA-paclitaxel used for?

DHA-paclitaxel is indicated for Breast cancer, Ovarian cancer, Lung cancer.

Who makes DHA-paclitaxel?

DHA-paclitaxel is developed by Theradex (see full Theradex pipeline at /company/theradex).

What drug class is DHA-paclitaxel in?

DHA-paclitaxel belongs to the Taxane class. See all Taxane drugs at /class/taxane.

What development phase is DHA-paclitaxel in?

DHA-paclitaxel is in Phase 2.

What are the side effects of DHA-paclitaxel?

Common side effects of DHA-paclitaxel include Neutropenia, Anemia, Thrombocytopenia.

What does DHA-paclitaxel target?

DHA-paclitaxel targets Beta-tubulin and is a Taxane.

Related

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