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TAK-853

Takeda · Phase 1 active Small molecule ✓ Verified May 2026

TAK-853 is a Small molecule drug developed by Takeda. It is currently in Phase 1 development. Also known as: Mirvetuximab Soravtansine.

TAK-853 is a small molecule being studied in a Phase 1/2 clinical trial for its potential in treating folate receptor alpha-positive advanced ovarian cancer and other solid tumors. The trial, identified as NCT06390995, is being conducted by Takeda.

Likelihood of approval
12.6% vs 9.6% industry baseline
If approved by FDA: likely 2033–2036
Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 1 → approval rate +9.6pp
    Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
  • Big-pharma sponsor +3.0pp
    Takeda is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2033–2036 —
EMA EU 2034–2037 +0.7 yr
MHRA GB 2034–2037 +0.7 yr
Health Canada CA 2034–2038 +0.9 yr
TGA AU 2034–2038 +1.2 yr
PMDA JP 2034–2038 +1.5 yr
NMPA CN 2035–2039 +2.3 yr
MFDS KR 2034–2038 +1.4 yr
CDSCO IN 2034–2039 +1.8 yr
ANVISA BR 2035–2039 +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 nameTAK-853
Also known asMirvetuximab Soravtansine
SponsorTakeda
ModalitySmall molecule
PhasePhase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

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 TAK-853

What is TAK-853?

TAK-853 is a Small molecule drug developed by Takeda.

Who makes TAK-853?

TAK-853 is developed by Takeda (see full Takeda pipeline at /company/takeda).

Is TAK-853 also known as anything else?

TAK-853 is also known as Mirvetuximab Soravtansine.

What development phase is TAK-853 in?

TAK-853 is in Phase 1.

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