Last reviewed 2026-05-26 · How we verify

TAS5315 Dose 1

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

TAS5315 Dose 1 is a Small molecule drug developed by Taiho Pharmaceutical Co., Ltd.. It is currently in Phase 2 development.

TAS5315 is a small molecule being studied in a Phase 2a clinical trial for the treatment of Chronic Spontaneous Urticaria. The trial involves three different doses of TAS5315, including Dose 1, and is being conducted by Taiho Pharmaceutical Co., Ltd.

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	TAS5315 Dose 1
Sponsor	Taiho 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

A Phase 2a Study of TAS5315 in Patients With Chronic Spontaneous Urticaria (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:

TAS5315 Dose 1 CI brief — competitive landscape report
TAS5315 Dose 1 updates RSS · CI watch RSS
Taiho Pharmaceutical Co., Ltd. portfolio CI

Frequently asked questions about TAS5315 Dose 1

What is TAS5315 Dose 1?

TAS5315 Dose 1 is a Small molecule drug developed by Taiho Pharmaceutical Co., Ltd..

Who makes TAS5315 Dose 1?

TAS5315 Dose 1 is developed by Taiho Pharmaceutical Co., Ltd. (see full Taiho Pharmaceutical Co., Ltd. pipeline at /company/taiho-pharmaceutical-co-ltd).

What development phase is TAS5315 Dose 1 in?

TAS5315 Dose 1 is in Phase 2.

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

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