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Tolvaptan IR
Tolvaptan IR is a Small molecule drug developed by Otsuka Pharmaceutical Development & Commercialization, Inc.. It is currently in Phase 2 development. Also known as: OPC-41061.
Tolvaptan IR is a small molecule that acts as a vasopressin V2 receptor antagonist. It is being studied as a potential treatment for Autosomal Dominant Polycystic Kidney Disease.
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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).
| 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 | Tolvaptan IR |
|---|---|
| Also known as | OPC-41061 |
| Sponsor | Otsuka Pharmaceutical Development & Commercialization, Inc. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- 8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD) (PHASE2)
- Dose-finding Study of New Tolvaptan Formulation in Subjects With ADPKD (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:
- Tolvaptan IR CI brief — competitive landscape report
- Tolvaptan IR updates RSS · CI watch RSS
- Otsuka Pharmaceutical Development & Commercialization, Inc. portfolio CI
Frequently asked questions about Tolvaptan IR
What is Tolvaptan IR?
Who makes Tolvaptan IR?
Is Tolvaptan IR also known as anything else?
What development phase is Tolvaptan IR in?
Related
- Manufacturer: Otsuka Pharmaceutical Development & Commercialization, Inc. — full pipeline
- Also known as: OPC-41061
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing