Last reviewed 2026-06-03 · How we verify

TAK-188

Takeda · Phase 1 active Small molecule ✓ Verified Jun 2026

TAK-188 is a Small molecule drug developed by Takeda. It is currently in Phase 1 development.

TAK-188 is a small molecule RAF serine/threonine protein kinase inhibitor used in a Phase 1/2 trial to evaluate its safety, tolerability, and efficacy in adults with advanced or metastatic solid tumors. The trial, NCT07205718, is sponsored by Takeda and aims to assess the pharmacokinetics, pharmacodynamics, and efficacy of TAK-188 in this patient population.

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 name	TAK-188
Sponsor	Takeda
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Study of TAK-188 in Adults With Advanced or Spreading Solid Tumors (PHASE1, PHASE2)

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:

TAK-188 CI brief — competitive landscape report
TAK-188 updates RSS · CI watch RSS
Takeda portfolio CI

Frequently asked questions about TAK-188

What is TAK-188?

TAK-188 is a Small molecule drug developed by Takeda.

Who makes TAK-188?

TAK-188 is developed by Takeda (see full Takeda pipeline at /company/takeda).

What development phase is TAK-188 in?

TAK-188 is in Phase 1.

Manufacturer: Takeda — full pipeline

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