SAMSCA (tolvaptan)
SAMSCA is indicated for the treatment of Hyponatremia; Heart Failure; Syndrome of Inappropriate Antidiuretic Hormone.
How SAMSCA Works
Tolvaptan is a selective vasopressin V2-receptor antagonist with an affinity for the V2-receptor approximately 29 times greater than for the V1a-receptor. By antagonizing the V2-receptors in the renal collecting ducts, tolvaptan promotes aquaresis—the excretion of electrolyte-free water. This leads to an increase in free water clearance, a decrease in urine osmolality, and a resulting increase in serum sodium concentrations. Notably, tolvaptan does not significantly change the urinary excretion of sodium or potassium.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2009-05-19
- Patent Cliff
- 2030
- Routes
- ORAL
- Dosage Forms
- TABLET
SAMSCA Approval History
What SAMSCA Treats
3 indicationsSAMSCA is approved for 3 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hyponatremia
- Heart Failure
- Syndrome of Inappropriate Antidiuretic Hormone
SAMSCA Boxed Warning
(A) INITIATE AND RE-INITIATE IN A HOSPITAL AND MONITOR SERUM SODIUM (B) NOT FOR USE FOR AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD) WARNING: (A) INITIATE AND RE-INITIATE IN A HOSPITAL AND MONITOR SERUM SODIUM (B) NOT FOR USE FOR AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD) See full prescribing information for complete boxed warning. (A) Initiate and re-initiate in a hospital and monitor serum sodium SAMSCA should be initiated and re-initiated in patients only in a hospital where...
WARNING: (A) INITIATE AND RE-INITIATE IN A HOSPITAL AND MONITOR SERUM SODIUM (B) NOT FOR USE FOR AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD) WARNING: (A) INITIATE AND RE-INITIATE IN A HOSPITAL AND MONITOR SERUM SODIUM (B) NOT FOR USE FOR AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD) See full prescribing information for complete boxed warning. (A) Initiate and re-initiate in a hospital and monitor serum sodium SAMSCA should be initiated and re-initiated in patients only in a hospital where serum sodium can be monitored closely. Too rapid correction of hyponatremia (e.g., >12 mEq/L/24 hours) can cause osmotic demyelination resulting in dysarthria, mutism, dysphagia, lethargy, affective changes, spastic quadriparesis, seizures, coma and death. In susceptible patients, including those with severe malnutrition, alcoholism or advanced liver disease, slower rates of correction may be advisable. (B) Not for use for autosomal dominant polycystic kidney disease (ADPKD) Because of the risk of hepatotoxicity, tolvaptan should not be used for ADPKD outside of the FDA-approved REMS (4) (A) Initiate and re-initiate in a hospital and monitor serum sodium SAMSCA should be initiated and re-initiated in patients only in a hospital where serum sodium can be monitored closely. Too rapid correction of hyponatremia (e.g., >12 mEq/L/24 hours) can cause osmotic demyelination resulting in dysarthria, mutism, dysphagia, lethargy, affective changes, spastic quadriparesis, seizures, coma and death. In susceptible patients, including those with severe malnutrition, alcoholism or advanced liver disease, slower rates of correction may be advisable. (B) Not for use for autosomal dominant polycystic kidney disease (ADPKD) Because of the risk of hepatotoxicity, tolvaptan should not be used for ADPKD outside of the FDA-approved REMS [see Contraindications (4) ].
SAMSCA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to SAMSCA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
45 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06506994 | HRS-9057-103 | Ph 1 | completed | A Study of HRS-9057 in Patients With Heart Failure and Volume Overload |
| NCT07166887 | 156-11-808-01 | Ph 1 | completed | Phase I Study Multi Dose of 7.5mg Tolvaptan in Health Male |
| NCT07166783 | 156-11-807-01 | Ph 1 | completed | Single Dose of 7.5mg Tolvaptan Phase I Clinical Trial Protocol |
| NCT00664014 | 156-07-802-01 | Ph 2 | completed | A Phase 2 Efficacy and Safety Study of the Tolvaptan Tablets in Patients With Non-hypovolemic Non-acute Hyponatremia |
| NCT03255226 results posted | 156-102-00123 JapicCTI-173674 | Ph 3 | completed | Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of Tolvaptan in Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload |
| NCT02964273 results posted | 156-12-298 2016-000187-42 | Ph 3 | completed | Safety, Pharmacokinetics, Tolerability and Efficacy of Tolvaptan in Children and Adolescents With ADPKD (Autosomal Dominant Polycystic Kidney Disease) |
| NCT03541447 TOOL | TOOL 2017-004701-40 | Ph 2 | completed | Tolvaptan-Octreotide LAR Combination in ADPKD |
| NCT03949894 ESSENTIAL | 156-402-00144 | Ph 4 | completed | Evaluating the Safety and effectivenesS in Adult KorEaN Patients Treated With Tolvaptan for Management of Autosomal domInAnt poLycystic Kidney Disease |
| NCT02476409 TROUPER results posted | 15-0472 | Ph 4 | completed | Tolvaptan For Worsening Outpatient Heart Failure: Role of Copeptin In Identifying Responders |
| NCT01552590 ECF | 156-KOB-1101i | Ph 4 | terminated | Effect of Samsca on Control of Hyponatremia and Extracellular Fluid in Cirrhotic Patients With Ascites |
| NCT01214421 TEMPO 4/4 results posted | 156-08-271 2010-018401-10 | Ph 3 | completed | Tolvaptan Extension Study in Participants With ADPKD |
| NCT01199198 results posted | 2009-0862 | Ph 4 | completed | Tolvaptan in Hyponatremic Cancer Patients |
| NCT02959411 | REB16-0064 | Ph 4 | terminated | Tolvaptan for Advanced or Refractory Heart Failure |
| NCT02020278 results posted | 156-11-294 | Ph 3 | terminated | An Extension Follow-up Trial to Evaluate the Long-term Safety of Children and Adolescent Participants With Euvolemic or Hypervolemic Hyponatremia |
| NCT02251275 results posted | 156-13-211 | Ph 3 | completed | Long Term Safety of Immediate-release Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease |
| NCT02606253 results posted | VU-IRB-TBD | Ph 4 | completed | Comparison of Oral or Intravenous Thiazides vs Tolvaptan in Diuretic Resistant Decompensated Heart Failure |
| NCT01439009 results posted | 156-10-005 JapicCTI-111621 | Ph 4 | completed | Effect of Tolvaptan on Mid- to Long-term Prognosis of Heart Failure Patients |
| NCT02183792 AQUA-AHF results posted | HS-13-00705 | Ph 4 | completed | Aquaresis Utility for Hyponatremic Acute Heart Failure Study |
| NCT01336972 results posted | 156-09-284 2010-019025-33 | Ph 2 | completed | Short-term Renal Hemodynamic Effects of Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD) |
| NCT01280721 results posted | 156-10-003 JapicCTI-101362 | Ph 3 | completed | A Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan] |
| NCT03803124 POLY | FHM-1-2015 | Ph 3 | completed | Effect of Tolvaptan on Renal Plasma Flow (RPF) and Glomerular Filtration Rate (GFR) in ADPKD |
| NCT02012959 results posted | 156-08-276 2013-002005-59 | Ph 3 | terminated | Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia |
| NCT01890694 results posted | 10-02496 | Ph 4 | terminated | Tolvaptan to Reduce Length of Stay in Hospitalized Patients With Cirrhosis and Hyponatremia |
| NCT02173288 | Mido-tolvaptan 1 | Ph 2, Ph 3 | completed | Role of Midodrine and Tolvaptan in Patients With Cirrhosis With Refractory or Recurrent Ascites |
| NCT02442674 | 156-13-207 | Ph 3 | withdrawn | A Trial of Tolvaptan in Children and Adolescent Subjects With Euvolemic and Hypervolemic Hyponatremia |
| NCT02352285 AQUATIC | 156-KOB-1201i | Ph 4 | terminated | Outcome and Treatment Quality Study of Tolvaptan to Treat Hyponatremia in Patients With Heart Failure |
| NCT01346072 results posted | TOLCOPEP11 | Ph 4 | completed | Pilot Study of Using Copeptin to Predict Response to Tolvaptan |
| NCT01644331 TACTICS-HF results posted | Pro00037557 | Ph 3 | completed | Targeting Acute Congestion With Tolvaptan in Congestive Heart Failure |
| NCT02527863 TOPO | SAFA-2-2014 2014-001973-15 | Ph 2 | completed | Effect of the Aquaretic Tolvaptan on Nitric Oxide System |
| NCT01386372 INSERT | INSERT 2010-024431-17 | Ph 2 | terminated | Tolvaptan for In-hospital Hyponatremia |
| NCT01973140 | STU00071984 | Ph 4 | completed | Effects of Tolvaptan in Healthy Adults |
| NCT02009878 results posted | 156-12-203 | Ph 1, Ph 2 | completed | A PK Study of 3 Dosages of Tolvaptan in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) |
| NCT02096965 | 11-001780 | Ph 1 | completed | Use of Tolvaptan to Reduce Urinary Supersaturation: a Pilot Proof of Principle Study |
| NCT01863511 TUF | TUF-01 | Ph 4 | completed | Tolvaptan/Ultrafiltration in the Treatment of Acute Heart Failure |
| NCT01663662 | 11-PAF06621 | Ph 4 | withdrawn | The Use of Tolvaptan to Prevent Renal Dysfunction in High Risk Patients With Heart Failure-Pilot Study |
| NCT01292304 results posted | 156-IST-10-06 | Ph 4 | completed | Tolvaptan for Ascites in Cirrhotic Patients |
| NCT01618448 | 156-TWA-1101 | Ph 3 | completed | Efficacy and Safety of Tolvaptan in the Treatment of Cardiac-Induced Edema in Patients With Heart Failure |
| NCT01227512 SALACIA results posted | 156-08-275 | Ph 3 | terminated | Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional Hyponatremia |
| NCT01638663 | SAFA-1-2012 | Ph 2 | completed | Effect of the Aquaretic Tolvaptan on Nitric Oxide System (TORA) |
| NCT01556646 | Bajaj 01720 | Ph 3 | completed | Effect of Tolvaptan on Cognitive Function in Cirrhosis |
| NCT01651156 | 156-12-809-01 | Ph 3 | completed | Efficacy and Safety Study of Tolvaptan to Treat Patients With Cardiac Edema |
| NCT01261481 | 10-1865 | Ph 1 | completed | Bioavailability Study Comparing Tolvaptan Administered Via Nasogastric Tube to Tolvaptan Tablets Swallowed Intact |
| NCT01349335 | 156-08-804-01 | Ph 2 | completed | Dose Exploring and Setting Study for Tolvaptan to Treat Hepatic Cirrhosis With Ascites |
| NCT01349348 | 156-08-805-01 | Ph 3 | completed | Phase III Study of Tolvaptan Tablet to Treat Cirrhosis Ascites |
| NCT01359462 | 156-09-806-01 | Ph 1 | completed | Multiple-dose Pharmacokinetics Study of Tolvaptan Tablets in Chinese Patients With Hepatocirrhosis |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SAMSCA FDA Label Details
Indications & Usage
FDA Label (PDF)SAMSCA is indicated for the treatment of Hyponatremia; Heart Failure; Syndrome of Inappropriate Antidiuretic Hormone.
WARNING: (A) INITIATE AND RE-INITIATE IN A HOSPITAL AND MONITOR SERUM SODIUM (B) NOT FOR USE FOR AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD) WARNING: (A) INITIATE AND RE-INITIATE IN A HOSPITAL AND MONITOR SERUM SODIUM (B) NOT FOR USE FOR AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD) ...
SAMSCA Patents & Exclusivity
Patents (2 active)
Pro Intelligence Preview
Deep insights for SAMSCA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2030
- • 18 active patents
Trial Analysis
- • 48 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment