Drugs / Tolvaptan
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed autosomal dominant polycystic kidney disease 5 milestones | |||||
| Filed | US (FDA) | — | autosomal dominant polycystic kidney disease | 2017-10-24 | “FDA Accepts Otsuka’s Resubmission To Support A Regulatory Review Of Tolvaptan In The Treatment Of ADPKD” otsuka-us.com ↗ |
| Filed | EU (EMA) | — | autosomal dominant polycystic kidney disease | 2013-12-27 | “the European Medicines Agency (EMA) has accepted the submission of a marketing authorisation application (MAA) for the potential approval of tolvaptan” otsuka.co.jp ↗ |
| Rejected (CRL) | US (FDA) | — | autosomal dominant polycystic kidney disease | 2013-08-30 | “received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the new drug application (NDA) for tolvaptan” otsuka.co.jp ↗ “Complete Response Letter issued by the U.S. FDA in 2013 for a New Drug Application for tolvaptan in the treatment of adults with ADPKD.” otsuka-us.com ↗ “the Complete Response Letter (CRL) issued by the FDA for a New Drug Application (NDA) for tolvaptan in ADPKD in 2013” otsuka-us.com ↗ “Complete Response Letter (CRL) issued by the FDA for a New Drug Application (NDA) for tolvaptan in ADPKD in 2013” otsuka-us.com ↗ |
| Filed | Japan (PMDA) | — | autosomal dominant polycystic kidney disease | 2013-05-30 | “filed an application with the Pharmaceutical and Medical Devices Agency in Japan (PMDA) to market its novel compound tolvaptan” otsuka.co.jp ↗ |
| Filed | US (FDA) | — | autosomal dominant polycystic kidney disease | 2013-04-12 | “accepted for priority review the company's new drug application (NDA) for the potential use of tolvaptan” otsuka.co.jp ↗ |
| Filed cirrhosis of liver 1 milestone | |||||
| Filed | Japan (PMDA) | Samsca | cirrhosis of liver | — | “today announced that it applied in July to Japan's Ministry of Health, Labour and Welfare for an additional indication for Samsca Tablets (tolvaptan)” otsuka.co.jp ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Samsca | — | 2009-08-02 | europa.eu ↗ |
| Approved | US (FDA) | SAMSCA | — | 2009-05-19 | fda.gov ↗ |
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News releases announcing trial results or a regulatory action · 31
| Date | Issuer | Release |
|---|---|---|
| 2026-08-17 | Otsuka Pharmaceutical Factory, Inc. | Regulatory Otsuka Pharmaceutical Factory obtains approval for the manufacture and sale of the vasopressin V₂-receptor antagonist “Tolvaptan OD tablets 30 mg Otsuka” otsukakj.jp ↗
Otsuka Pharmaceutical Factory, Inc. (Head Office: Naruto, Tokushima, Japan; President and Representative Director: Shuichi Takagi; hereinafter “Otsuka Pharmaceutical Factory”) announces that it has obtained approval today for the manufacture and sale of “Tolvaptan OD tablets 30 mg Otsuka” (nonproprietary name: tolvaptan; hereinafter “the Product”), a vasopressin V2-receptor antagonist. |
| 2022-03-28 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka Obtains Approval in Japan for SAMTASU for I.V. Infusion, a V2 -Receptor Antagonist for the Treatment of Cardiac Edema® otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that it has received regulatory approval in Japan for the manufacture and sale of SAMTASU 8mg and 16mg Intravenous Infusion for the treatment of cardiac edema. |
| 2021-03-22 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results Otsuka Has Filed an Application in Japan for Regulatory Approval of OPC-61815, a V -Receptor Antagonist for the Treatment of Cardiac Edema2 otsuka.co.jp ↗
The phase 3 trial outcomes showed non-inferiority of OPC-61815 versus tolvaptan 15mg tablet in the primary endpoint of change in body weight from baseline at the final dose. |
| 2020-06-29 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Samscaapproved in Japan for additional indication of hyponatremia due to syndrome of inappropriate antidiuretic hormone secretion (SIADH)® otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. announces that the oral vasopressin V-receptor antagonists Samsca Tablets, Samsca OD Tablets and SAMSCA Granules 1% have received regulatory approval in Japan for the indication of hyponatraemia secondary to the syndrome of inappropriate antidiuretic hormone secretion (SIADH) in adults. |
| 2019-08-28 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Approval for the Additional Formulation of Samsca OD Tablets in Japan® otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. announces the granting of approval in Japan for the additional dosage form of Samsca OD Tablets (tolvaptan), a vasopressin V-receptor antagonist. |
| 2018-04-25 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka's JYNARQUE™ (tolvaptan) Approved by U.S. FDA as the First Treatment to Slow Kidney Function Decline in Adults at Risk of Rapidly Progressing Autosomal Dominant Polycystic Kidney Disease (ADPKD) otsuka.co.jp ↗
the U.S. Food and Drug Administration (FDA) has approved JYNARQUE (tolvaptan) as the first drug treatment available to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). |
| 2018-04-24 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka’s JYNARQUE™ (tolvaptan) Approved by U.S. FDA as the First Treatment to Slow Kidney Function Decline in Adults at Risk of Rapidly Progressing Autosomal Dominant Polycystic Kidney Disease (ADPKD) otsuka-us.com ↗
Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that the U.S. Food and Drug Administration (FDA) has approved JYNARQUE™ (tolvaptan) as the first drug treatment to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). |
| 2017-11-09 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory U.S. FDA Accepts Otsuka's Resubmission to Support a Regulatory Review of Tolvaptan in the Treatment of ADPKD otsuka.co.jp ↗
The FDA considers the resubmission to be filed as of October 24, 2017, with a PDUFA action date of April 24, 2018. |
| 2017-11-08 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory FDA Accepts Otsuka’s Resubmission To Support A Regulatory Review Of Tolvaptan In The Treatment Of ADPKD otsuka-us.com ↗ |
| 2017-11-05 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results Otsuka Announces Phase 3 Results for Tolvaptan in Patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. (Otsuka) announced detailed results from the Phase 3 REPRISE trial of tolvaptan, which is under investigation in the United States in patients with autosomal dominant polycystic kidney disease (ADPKD). |
| 2017-11-04 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results Otsuka Announces Phase 3 Results for Tolvaptan in Patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) otsuka-us.com ↗
Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced detailed results from the Phase 3 REPRISE trial of tolvaptan, which is under investigation in the United States in patients with autosomal dominant polycystic kidney disease (ADPKD). |
| 2017-05-22 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results Otsuka Announces Results of Phase 3 Data on Tolvaptan Under Development for ADPKD in U.S. otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. announces positive top-line results from an additional Phase 3 clinical trial of tolvaptan in adult patients with ADPKD. |
| 2017-05-21 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results Otsuka Announces Results of Phase 3 Data on Tolvaptan Under Development for ADPKD in U.S. otsuka-us.com ↗
Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces positive top-line results from an additional Phase 3 clinical trial of tolvaptan in adult patients with ADPKD. |
| 2017-03-16 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Approval for the Additional Formulation of Samsca Granules 1% in Japan® otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. announces the granting of approval in Japan for the additional dosage form of Samsca granules 1% (tolvaptan), a vasopressin V-receptor antagonist. |
| 2015-05-28 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka's JINARC the First-Ever Treatment Approved in Europe for Adults Living with ADPKD, a Chronic Genetic Kidney Disease® otsuka.co.jp ↗
In receiving this marketing authorisation, tolvaptan becomes the first pharmaceutical therapy to be licensed in Europe for the treatment of the underlying pathophysiology of ADPKD. |
| 2015-02-27 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory CHMP Recommends JINARC (Tolvaptan) for Approval in EU: The First Pharmaceutical Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD)® otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended JINARC (tolvaptan) for approval. |
| 2015-02-27 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory First-ever treatment approved in Canada for adults living with ADPKD, a life-threatening kidney disease otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. and its affiliate Otsuka Canada Pharmaceutical Inc. announce that Health Canada has approved JINARC (tolvaptan) as the first pharmaceutical agent for the treatment of autosomal dominant polycystic kidney disease (ADPKD). |
| 2014-03-24 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka Pharmaceutical's Samsca Approved in Japan as the World's First Drug Therapy for ADPKD, a Rare Kidney Disease® otsuka.co.jp ↗
Samsca, discovered and developed by Otsuka Pharmaceutical Co., has been approved in Japan as the first drug treatment in the world to slow the progression of autosomal dominant polycystic kidney disease (ADPKD). |
| 2013-12-27 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory European Medicines Agency (EMA) Accepts Otsuka's Marketing Authorisation Application (MAA) for Tolvaptan, an Investigational Compound for Autosomal Dominant Polycystic Kidney Disease (ADPKD) otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. announced today that the European Medicines Agency (EMA) has accepted the submission of a marketing authorisation application (MAA) for the potential approval of tolvaptan for the treatment of autosomal dominant polycystic kidney disease (ADPKD). |
| 2013-09-17 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Vasopressin V2 Receptor Antagonist Samsca7.5mg Tablets Granted Additional Indication in Japan for the Treatment of Fluid Retention in Patients with Hepatic Cirrhosis® otsuka.co.jp ↗
Approval of this new indication in Japan is the first such approval in the world, offering a new treatment option to hepatic cirrhosis patients experiencing difficulties or inadequacy with conventional diuretic treatments. |
| 2013-08-30 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka Receives Complete Response Letter From U.S. Food And Drug Administration For Tolvaptan For Use In Patients With Autosomal Dominant Polycystic Kidney Disease otsuka.co.jp ↗
In its letter to Otsuka, the FDA requested Otsuka provide additional data to further evaluate the efficacy and safety of tolvaptan in patients with ADPKD. |
| 2013-08-06 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory U.S. Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee Recommends Against Approval of Otsuka Pharmaceutical's Tolvaptan for Use in Autosomal Dominant Polycystic Kidney Disease (ADPKD) otsuka.co.jp ↗
The Advisory Committee voted 9 to 6 not to approve tolvaptan for ADPKD. |
| 2013-08-05 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory U.S. Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee Recommends Not to Approve Otsuka Pharmaceutical’s Tolvaptan for Use in Autosomal Dominant Polycystic Kidney Disease (ADPKD) otsuka-us.com ↗
Otsuka Pharmaceutical Co., Ltd. announced today the U.S. Food and Drug Administration’s (FDA's) Cardiovascular and Renal Drugs Advisory Committee voted 9 to 6 not to approve tolvaptan for the treatment of ADPKD. |
| 2013-06-03 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka Pharmaceutical Submits New Drug Application in Japan for Tolvaptan for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD) otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. Today announced it filed an application with the Pharmaceutical and Medical Devices Agency in Japan (PMDA) to market its novel compound tolvaptan for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD). |
| 2013-04-12 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka's New Drug Application For Tolvaptan, An Investigational Compound For Autosomal Dominant Polycystic Kidney Disease (ADPKD), Accepted For Review By The US Food And Drug Administration (FDA) otsuka.co.jp ↗ |
| 2013-02-08 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory 7.5mg Tablets Additionally Approved - Samsca, Vasopressin V2 Receptor Antagonist® otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. today announced that Samsca (tolvaptan), vasopressin V2 receptor antagonist indicated for the treatment of volume overload in patients with heart failure, was granted additional approval of tablets in 7.5mg dosage on February 4, 2013. |
| 2012-11-05 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results Otsuka's Investigational Compound for Autosomal Dominant Polycystic Kidney Disease (ADPKD), Tolvaptan, Meets Primary Endpoint in a Phase III Clinical Trial otsuka.co.jp ↗
Tolvaptan met its primary endpoint of demonstrating a statistically significant (p<0.001) reduction (nearly 50% reduction) in the rate of increase in Total Kidney Volume (TKV) over the 3-year study period as compared to placebo among patients with ADPKD. |
| 2012-08-01 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Vasopressin V2-Receptor Antagonist, Samsca Tablets Were Filed Additional Indication of the Treatment of Fluid Retention Associated with Cirrhosis of the Liver® otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. today announced that it applied in July to Japan's Ministry of Health, Labour and Welfare for an additional indication for Samsca Tablets (tolvaptan), a V2-vasopressin receptor antagonist, as the world's first aquaretic treatment for fluid retention associated with cirrhosis of the liver. |
| 2010-10-27 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory SAMSCA Tablets 15mg (tolvaptan), Vasopressin V-Receptor Antagonist, Receive Regulatory Approval in Japan™2 otsuka.co.jp ↗ |
| 2009-08-04 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory The European Commission Approves SAMSCA (tolvaptan), Europe's First and Only Oral Vasopressin Antagonist for Hyponatraemia Secondary to Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) .™ otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. and Otsuka Pharmaceutical Europe Ltd. (OPEL) announced today that the European Commission has approved the Marketing Authorisation Application for the company's oral once-daily medication SAMSCA(tolvaptan), a selective V2-vasopressin receptor antagonist, for the treatment of hyponatraemia secondary to syndrome of inappropriate antidiuretic hormone secretion (SIADH) in adults. |
| 2009-05-21 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory FDA Approves SAMSCA (tolvaptan), The First and Only Oral Vasopressin Antagonist to Treat Patients with Clinically Significant Hypervolemic and Euvolemic Hyponatremia™ otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. (OPC) and Otsuka Pharmaceutical Development and Commercialization, Inc. (OPDC) announced today that the U.S. Food and Drug Administration (FDA) has approved SAMSCATM (tolvaptan) as the only oral selective vasopressin antagonist for the treatment of patients with clinically significant hypervolemic and euvolemic hyponatremia (serum sodium less than 125 mEq/L, or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction) including patients with heart failure, cirrhosis, and the syndrome of inappropriate anti-diuretic hormone (SIADH). |
All press releases naming this drug 39 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 86 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tolvaptan | “the V2 receptor antagonist tolvaptan (Samsca™, 30mg tablet), or the V2 receptor agonist desmopressin (DDAVP™, 0.2mg tablet) was ingested” NCT02084797 ↗84“single dose of 15mg Tolvaptan tablet with no feeding.” NCT07166796 ↗ |
| Known as | OPC-41061 | “Tolvaptan (OPC-41061) Tolvaptan tablets will be administered orally as split-dose regimens (15/7.5 mg, 30/15 mg, and 45/15 mg) upon awakening and 8 hours later (twice daily)...” NCT04782258 ↗ |
| Known as | Samsca | “The investigators plan to use Tolvaptan (Samsca), an oral ADH antagonist that promotes aquauresis, as an agent to treat neurologically and hemodynamically stable patients with...” NCT02545114 ↗2“the V2 receptor antagonist tolvaptan (Samsca™, 30mg tablet), or the V2 receptor agonist desmopressin (DDAVP™, 0.2mg tablet) was ingested” NCT02084797 ↗ “Tolvaptan, Samsca, uncoated tablet, 30 mg, once per day, up to 7 days.” NCT01584557 ↗ |
| Action | Inhibit | “vasopressin V2 receptor antagonism with tolvaptan” PMID 17543634 ↗ May 2007 |
| Route | Oral | “oral tolvaptan” PMID 17543634 ↗ May 2007 |
| Target | AVP | “tolvaptan, an oral AVP inhibitor” NCT00201994 ↗ |