Last reviewed 2026-05-29 · How we verify

TAK-385 T2 Formulation

Takeda · Phase 1 active Small molecule ✓ Verified May 2026

TAK-385 T2 Formulation is a Small molecule drug developed by Takeda. It is currently in Phase 1 development.

TAK-385 T2 Formulation is a tablet formulation being studied in a Phase 1 clinical trial to assess its bioavailability and the effect of food on its absorption in healthy volunteers. The study, NCT02396147, is a randomized, three-way crossover study comparing TAK-385 T2 Formulation with two other formulations, TAK-385 T4 Formulation B and TAK-385 T4 Formulation C.

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-385 T2 Formulation
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

Bioavailability and Effect of Food on TAK-385 Tablet Formulations in Healthy Participants (PHASE1)

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-385 T2 Formulation CI brief — competitive landscape report
TAK-385 T2 Formulation updates RSS · CI watch RSS
Takeda portfolio CI

Frequently asked questions about TAK-385 T2 Formulation

What is TAK-385 T2 Formulation?

TAK-385 T2 Formulation is a Small molecule drug developed by Takeda.

Who makes TAK-385 T2 Formulation?

TAK-385 T2 Formulation is developed by Takeda (see full Takeda pipeline at /company/takeda).

What development phase is TAK-385 T2 Formulation in?

TAK-385 T2 Formulation is in Phase 1.

Manufacturer: Takeda — full pipeline

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