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Solifenacin Succinate Formulation A
Solifenacin Succinate Formulation A is a Small molecule drug developed by Astellas Pharma Inc. It is currently in Phase 1 development. Also known as: YM905.
Solifenacin succinate, a medication found in formulation EC905, is used to treat urinary bladder overactive conditions. It is often administered in combination with tamsulosin, as seen in the study NCT01953887, which compared the pharmacokinetics of EC905 containing both solifenacin and tamsulosin to separate tablets of each medication.
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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).
| 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 A |
|---|---|
| Also known as | YM905 |
| Sponsor | Astellas Pharma Inc |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Trial Comparing Combination Treatment (Solifenacin Plus Mirabegron) With One Treatment Alone (Solifenacin) (PHASE3)
- A Study to Compare the Amount of Drug in the Blood After a Single Tablet EC905 Containing Solifenacin and Tamsulosin is Taken by Healthy Males Compared to Separate Tablets of Solifenacin and Tamsulosin (PHASE1)
- 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 A CI brief — competitive landscape report
- Solifenacin Succinate Formulation A updates RSS · CI watch RSS
- Astellas Pharma Inc portfolio CI
Frequently asked questions about Solifenacin Succinate Formulation A
What is Solifenacin Succinate Formulation A?
Who makes Solifenacin Succinate Formulation A?
Is Solifenacin Succinate Formulation A also known as anything else?
What development phase is Solifenacin Succinate Formulation A in?
Related
- Manufacturer: Astellas Pharma Inc — full pipeline
- Also known as: YM905
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing