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Tolvaptan tablet 15mg
Tolvaptan tablet 15mg is a Small molecule drug developed by Otsuka Pharmaceutical Co., Ltd.. It is currently in Phase 1 development.
Tolvaptan is a small molecule that acts as a vasopressin V2 receptor antagonist. It is used to treat non-hypovolemic non-acute hyponatremia, among other conditions, and is available in a 15mg tablet form.
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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 | Tolvaptan tablet 15mg |
|---|---|
| Sponsor | Otsuka Pharmaceutical Co., Ltd. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- Cardiac failure congestive
- Dry mouth
- Vomiting
- Pyrexia
- Urinary tract infection
- Contusion
- Electrocardiogram QT prolonged
- Dizziness
- Jugular vein distension
- Ventricular tachycardia
- Dry eye
- Abdominal pain upper
Key clinical trials
- a Phase I PK Study in Healthy Male Subjects. 2 Groups of Healthy Male Subjects (PHASE1)
- A Phase 2 Efficacy and Safety Study of the Tolvaptan Tablets in Patients With Non-hypovolemic Non-acute Hyponatremia (PHASE2)
- Evaluating the Safety and effectivenesS in Adult KorEaN Patients Treated With Tolvaptan for Management of Autosomal domInAnt poLycystic Kidney Disease (PHASE4)
- Efficacy and Safety Trial of OPC-61815 Injection Compared With Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure (PHASE3)
- Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure (NA)
- A Trial to Investigate the Efficacy and Safety of Orally Administered Tolvaptan (OPC-41061) in Patients With Chronic Renal Failure Undergoing Hemodialysis or Hemodiafiltration (PHASE2)
- The Role of Vasopressin Antagonism on Renal Sodium Handling (PHASE1)
- Outcome and Treatment Quality Study of Tolvaptan to Treat Hyponatremia in Patients With Heart Failure (PHASE4)
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 tablet 15mg CI brief — competitive landscape report
- Tolvaptan tablet 15mg updates RSS · CI watch RSS
- Otsuka Pharmaceutical Co., Ltd. portfolio CI
Frequently asked questions about Tolvaptan tablet 15mg
What is Tolvaptan tablet 15mg?
Who makes Tolvaptan tablet 15mg?
What development phase is Tolvaptan tablet 15mg in?
What are the side effects of Tolvaptan tablet 15mg?
Related
- Manufacturer: Otsuka Pharmaceutical Co., Ltd. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing