Samsca
(tolvaptan)ApprovedSmall molecule
OtsukaTolvaptan is used to treat low sodium levels in the blood (a condition called hyponatremia) and to slow kidney disease progression in patients with a genetic disorder called autosomal dominant polycystic kidney disease (ADPKD).[2] Samsca is currently approved and in use across 14 indications[4].[1]
Samsca is one of 247 small molecule programs targeting Heart Failure. It is currently in Approved.
14
Indications
86
Total Trials
3
Active Trials
246
Competitors
2
FDA Applications
NDA/BLA/ANDA regulatory filings
2
Patents
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 13 indications
Competition
Competitive Landscape
242 competitors in Efficacy and Safety
#DrugCompanyPhaseTrials
1Samsca
OtsukaApproved
Lutathera
NovartisPhase 3
HLX10
Shanghai Henlius BiotechPhase 3
Romiplostim N01
Qilu Pharmaceutical Co., Ltd.Phase 3
NTQ5082
NNanjing Chia-tai Tianqing Pharmaceutical
Phase 3
S1,
CChinese Academy of Medical Sciences
Phase 3
HSK39297
Haisco Pharmaceutical Group Co., Ltd.Phase 3
Imlifidase
HHansa Biopharma AB
Phase 3
INZ-701
IInozyme Pharma
Phase 3
DFL24498
DDompé Farmaceutici S.p.A
Phase 3
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Hyponatremia16 trials
Show 13 more trials
Efficacy and Safety of Tolvaptan in Cirrhotic Patients With Hyponatremia
Completed·—··NCT01850940·98 enrolled
Heart Failure13 trials
Show 10 more trials
Autosomal Dominant Polycystic Kidney Disease11 trials
Metformin vs Tolvaptan for Treatment of Autosomal Dominant Polycystic Kidney Disease
Unknown status·AAzienda Ospedaliero-Universitaria Consorziale Policlinico di Bari·Phase 3·NCT03764605·150 enrolled
Show 8 more trials
Congestive Heart Failure7 trials
Show 4 more trials
Targeting Acute Congestion With Tolvaptan in Congestive Heart Failure
Completed·—·Phase 3·NCT01644331·257 enrolled
ADPKD6 trials
22 more indications
Cirrhosis5 trials
Role of Midodrine and Tolvaptan in Patients With Cirrhosis With Refractory or Recurrent Ascites
Completed·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 2/3·NCT02173288·50 enrolled
Nitric Oxide3 trials
Function1 trial
Critical Care1 trial
Acute1 trial
Tolvaptan for Patients With Acute Neurological Injuries
Terminated·—·N/A·NCT02545114·25 enrolled
ESS1 trial
The Role of Vasopressin Antagonism on Renal Sodium Handling
Completed·—·Phase 1·NCT03910231·30 enrolled
Polycystic Kidney Disease1 trial
Efficacy and Safety1 trial
Gastric1 trial
SIADH1 trial
Autosomal Recessive1 trial
Antidiuretic Hormone, Inappropriate Secretion1 trial
Unspecified6 trials
Regulatory
FDA Approval Timeline[5]
May 19, 2009
SAMSCA
NDA NDA022275
Apr 23, 2018
JYNARQUE
NDA NDA204441
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Samsca drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for tolvaptan. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]FDA Orange Book — Patent and exclusivity data for Samsca. U.S. Food & Drug Administration.
- [7]