Last reviewed 2026-05-27 · How we verify

Solifenacin Succinate Formulation B

Astellas Pharma Inc · Phase 1 active Small molecule ✓ Verified May 2026

Solifenacin Succinate Formulation B is a Small molecule drug developed by Astellas Pharma Inc. It is currently in Phase 1 development. Also known as: YM905.

Solifenacin Succinate Formulation B is a liquid formulation of the drug solifenacin succinate, which is a small molecule muscarinic acetylcholine receptor M3 antagonist. This formulation was studied in a phase 1 clinical trial in healthy volunteers to compare its pharmacokinetics with those of two other formulations, Solifenacin Succinate Formulation A and the tablet formulation of solifenacin succinate.

Likelihood of approval

9.6% 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).

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	Solifenacin Succinate Formulation B
Also known as	YM905
Sponsor	Astellas Pharma Inc
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 in Healthy Volunteers Comparing Two Different Liquid Formulations of Solifenacin With Each Other and With the Tablet Formulation (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:

Solifenacin Succinate Formulation B CI brief — competitive landscape report
Solifenacin Succinate Formulation B updates RSS · CI watch RSS
Astellas Pharma Inc portfolio CI

Frequently asked questions about Solifenacin Succinate Formulation B

What is Solifenacin Succinate Formulation B?

Solifenacin Succinate Formulation B is a Small molecule drug developed by Astellas Pharma Inc.

Who makes Solifenacin Succinate Formulation B?

Solifenacin Succinate Formulation B is developed by Astellas Pharma Inc (see full Astellas Pharma Inc pipeline at /company/astellas).

Is Solifenacin Succinate Formulation B also known as anything else?

Solifenacin Succinate Formulation B is also known as YM905.

What development phase is Solifenacin Succinate Formulation B in?

Solifenacin Succinate Formulation B is in Phase 1.

Manufacturer: Astellas Pharma Inc — full pipeline
Also known as: YM905

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