Last reviewed 2026-05-27 · How we verify

Step 1: TS-142

Taisho Pharmaceutical Co., Ltd. · Phase 2 active Small molecule ✓ Verified May 2026

Step 1: TS-142 is a Small molecule drug developed by Taisho Pharmaceutical Co., Ltd.. It is currently in Phase 2 development.

TS-142 was studied in a clinical trial (NCT04087707) to assess its safety, pharmacokinetics, and pharmacodynamics in healthy volunteers. The study involved administering TS-142 to healthy subjects and comparing the results to those of a placebo.

Likelihood of approval

15.3% 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).

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 name	Step 1: TS-142
Sponsor	Taisho Pharmaceutical Co., Ltd.
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Safety, Pharmacokinetic, and Pharmacodynamic Study of TS-142 in Healthy Subjects (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:

Step 1: TS-142 CI brief — competitive landscape report
Step 1: TS-142 updates RSS · CI watch RSS
Taisho Pharmaceutical Co., Ltd. portfolio CI

Frequently asked questions about Step 1: TS-142

What is Step 1: TS-142?

Step 1: TS-142 is a Small molecule drug developed by Taisho Pharmaceutical Co., Ltd..

Who makes Step 1: TS-142?

Step 1: TS-142 is developed by Taisho Pharmaceutical Co., Ltd. (see full Taisho Pharmaceutical Co., Ltd. pipeline at /company/taisho-pharmaceutical-co-ltd).

What development phase is Step 1: TS-142 in?

Step 1: TS-142 is in Phase 2.

Manufacturer: Taisho Pharmaceutical Co., Ltd. — full pipeline

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