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Tolvaptan or Samsca
Tolvaptan or Samsca is a Vasopressin V2 receptor antagonist Small molecule drug developed by Cardiovascular Clinical Sciences Inc. It is currently in Phase 3 development for Hyponatremia, Autonomic dysfunction in heart failure.
Tolvaptan is a selective, competitive antagonist of the vasopressin V2 receptor.
Tolvaptan, also known as Samsca, is a small molecule that acts as a vasopressin V2 receptor antagonist. It is used to treat conditions such as hyponatremia, SIADH, heart failure, non-hypovolemic non-acute hyponatremia, and chronic renal failure.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 or Samsca |
|---|---|
| Sponsor | Cardiovascular Clinical Sciences Inc |
| Drug class | Vasopressin V2 receptor antagonist |
| Target | Vasopressin V2 receptor |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
By blocking the V2 receptor, tolvaptan reduces water reabsorption in the kidneys, leading to increased urine production and decreased fluid volume in the body. This mechanism is particularly useful in treating conditions such as hyponatremia and heart failure.
Approved indications
- Hyponatremia
- Autonomic dysfunction in heart failure
Common side effects
- Headache
- Diarrhea
- Nausea
- Fatigue
- Dizziness
Key clinical trials
- A Study to See Iftolvaptan is Safe in Infants and Children Who at Enrollment Are 28 Days to Less Than 18 Years Old withAutosomal Recessive Polycystic Kidney Disease (ARPKD) (PHASE3)
- Probenecid (PB) to Treat Hereditary Nephrogenic Diabetes Insipidus (NDI), ADPKD Treated With Tolvaptan, and Severely Polyuric Patients With Previous Lithium Administration (PHASE2)
- Canadian Medical Assessment of JINARC™ Outcomes Registry
- A Study to See if Tolvaptan Can Delay Dialysis in Infants and Children Who at Enrollment Are 28 Days to Less Than 12 Weeks Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD) (PHASE3)
- A Phase 2 Efficacy and Safety Study of the Tolvaptan Tablets in Patients With Non-hypovolemic Non-acute Hyponatremia (PHASE2)
- Samtasu Post-marketing General Drug Use-results Survey in Patients with Volume Overload in Heart Failure.
- The German ADPKD Tolvaptan Treatment Registry
- Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of Tolvaptan in Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload (PHASE3)
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 or Samsca CI brief — competitive landscape report
- Tolvaptan or Samsca updates RSS · CI watch RSS
- Cardiovascular Clinical Sciences Inc portfolio CI
Frequently asked questions about Tolvaptan or Samsca
What is Tolvaptan or Samsca?
How does Tolvaptan or Samsca work?
What is Tolvaptan or Samsca used for?
Who makes Tolvaptan or Samsca?
What drug class is Tolvaptan or Samsca in?
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What are the side effects of Tolvaptan or Samsca?
What does Tolvaptan or Samsca target?
Related
- Drug class: All Vasopressin V2 receptor antagonist drugs
- Target: All drugs targeting Vasopressin V2 receptor
- Manufacturer: Cardiovascular Clinical Sciences Inc — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Hyponatremia
- Indication: Drugs for Autonomic dysfunction in heart failure
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing