Tolvaptan

also known as OPC-41061 · Samsca · Jinarc · Jynarque · OPC-41061(TOLVAPTAN) · Tolvaptan accord

Small molecule targets AVP, AVPR2 via inhibition

Developed for: autosomal dominant polycystic kidney disease · congestive heart failure · cirrhosis of liver · heart failure · inappropriate ADH syndrome · chronic renal failure syndrome · autosomal recessive polycystic kidney disease · carcinoma
+10 more
· cardiomyopathy · chronic kidney disease · cystinuria · hepatic encephalopathy · nephrolithiasis, calcium oxalate · pulmonary arterial hypertension · pulmonary edema · symptomatic heart failure · water intoxication · tricuspid valve insufficiency
Investigated by: Otsuka Pharmaceutical Co., Ltd. · Otsuka Pharmaceutical Development & Commercialization, Inc. · Otsuka America Pharmaceutical · Otsuka Beijing Research Institute · Korea Otsuka Pharmaceutical Co., Ltd. · University of North Carolina, Chapel Hill
+35 more
· NYU Langone Health · Syneos Health · A.O. Ospedale Papa Giovanni XXIII · Assistance Publique - Hôpitaux de Paris · Beijing 302 Hospital · Beijing Anzhen Hospital · Beijing Friendship Hospital · Brigham and Women's Hospital · Caleb Nelson · Cardiology Research UBC · Chinese Academy of Medical Sciences, Fuwai Hospital · Chinese Pulmonary Vascular Disease Research Group · Duke University · Emory University · Fujian Shengdi Pharmaceutical Co., Ltd. · Georgetown University · Hunter Holmes Mcguire Veteran Affairs Medical Center · Jiangsu HengRui Medicine Co., Ltd. · Kyorin University · M.D. Anderson Cancer Center · Maisel, Alan, M.D. · Mario Negri Institute for Pharmacological Research · Mayo Clinic · Northwestern University · Oakland University · Otsuka Pharmaceutical Europe Ltd · Polderman, Kees, H., MD, PhD · Post Graduate Institute of Medical Education and Research, Chandigarh · Taiwan Otsuka Pharm. Co., Ltd · Thermo Fisher Scientific, Inc · University of Calgary · University of Florida · University of Pittsburgh · University of Southern California · Vanderbilt University

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Approved	EU (EMA)	Samsca	—	2009-08-02	europa.eu ↗
Approved	US (FDA)	SAMSCA	—	2009-05-19	fda.gov ↗

Trials 81 · started per year

today

US approved 2009

EU approved 2009

20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 111 trials
Phase 1	NCT06506994	Aug 2024 → Oct 2025	heart failure	Fujian Shengdi Pharmaceutical Co., Ltd.	Completed	No outcome recorded
Phase 1	NCT02994394	Jan → Feb 2017	—	Otsuka Pharmaceutical Co., Ltd.	Completed	No outcome recorded
Phase 1	NCT02646540	Jan 2016 → Dec 2018	cardiomyopathy, congestive heart failure	Emory University	Completed	No outcome recorded
Phase 1	NCT02096965	Mar 2014 → Nov 2015	nephrolithiasis, calcium oxalate	Mayo Clinic	Completed	No outcome recorded
Phase 1	NCT03910231	Feb 2012 → Sep 2014	—	Brigham and Women's Hospital	Completed	No outcome recorded
Phase 1	NCT07166783	Jun → Jul 2011	—	Otsuka Beijing Research Institute	Completed	No outcome recorded
Phase 1	NCT07166887	Jun → Jul 2011	—	Otsuka Beijing Research Institute	Completed	No outcome recorded
Phase 1	NCT01261481	Jan 2011 → Jan 2012	—	University of North Carolina, Chapel Hill	Completed	No outcome recorded
Phase 1	NCT01014416	Jan → Mar 2010	—	Korea Otsuka Pharmaceutical Co., Ltd.	Completed	No outcome recorded
Phase 1	NCT01359462	Apr → Nov 2009	cirrhosis of liver	Otsuka Beijing Research Institute	Completed	No outcome recorded
Phase 1	NCT07166796	Oct 2006 → Jan 2007	—	Otsuka Beijing Research Institute	Completed	No outcome recorded

Phase 1/21 trial
Phase 1/2	NCT02009878	Nov 2013 → Jun 2015	inappropriate ADH syndrome	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 218 trials
Phase 2	NCT03931369	Sep 2019 → Dec 2020	—	Assistance Publique - Hôpitaux de Paris	Unknown	No outcome recorded
Phase 2	NCT02331680	Dec 2014 → May 2016	chronic renal failure syndrome	Otsuka Pharmaceutical Co., Ltd.	Completed	No outcome recorded
Phase 2	NCT01895322	Jul 2013 → Feb 2014	chronic renal failure syndrome	Otsuka Pharmaceutical Co., Ltd.	Completed	No outcome recorded
Phase 2	NCT01876381	Jun 2013 → Feb 2014	chronic renal failure syndrome	Otsuka Pharmaceutical Co., Ltd.	Completed	No outcome recorded
Phase 2	NCT01684202	Jul 2012 → Dec 2013	carcinoma	Otsuka Pharmaceutical Co., Ltd.	Completed	No outcome recorded
Phase 2	NCT01451827	Oct 2011 → Jul 2013	autosomal dominant polycystic kidney disease	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 2	NCT01386372	Jun 2011 → Nov 2012	—	Mario Negri Institute for Pharmacological Research	Terminated	No outcome recorded
Phase 2	NCT01336972	Oct 2010 → Nov 2011	autosomal dominant polycystic kidney disease	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 2	NCT01210560	Oct 2010 → Jun 2011	autosomal dominant polycystic kidney disease	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 2	NCT01349335	Apr 2009 → Jan 2010	cirrhosis of liver	Otsuka Beijing Research Institute	Completed	No outcome recorded
Phase 2	NCT00664014	May 2008 → Feb 2010	—	Otsuka Beijing Research Institute	Completed	No outcome recorded
Phase 2	NCT00479336	Jun 2007 → Jan 2009	cirrhosis of liver	Otsuka Pharmaceutical Co., Ltd.	Completed	No outcome recorded
Phase 2	NCT00841568	Apr 2006 → Nov 2010	autosomal dominant polycystic kidney disease	Otsuka Pharmaceutical Co., Ltd.	Completed	No outcome recorded
Phase 2	NCT00413777	Dec 2005 → Jun 2010	autosomal dominant polycystic kidney disease	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 2	NCT00132886	Dec 2004 → Dec 2006	congestive heart failure	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 2	NCT00234104	Aug 2004 → Jan 2006	congestive heart failure	Otsuka Pharmaceutical Co., Ltd.	Completed	No outcome recorded
Phase 2	NCT00043758	Jul 2002 → Jul 2004	congestive heart failure	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 2	NCT00043771	May → Sep 2002	congestive heart failure	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded

Phase 2/32 trials
Phase 2/3	NCT02173288	Jul 2013 → Mar 2016	cirrhosis of liver	Post Graduate Institute of Medical Education and Research, Chandigarh	Completed	No outcome recorded
Phase 2/3	NCT01507727	Jan → Sep 2012	—	Jiangsu HengRui Medicine Co., Ltd.	Unknown	No outcome recorded
Phase 330 trials
Phase 3	NCT04782258	Jan 2023 → Jul 2028 expected	autosomal recessive polycystic kidney disease	Otsuka Pharmaceutical Development & Commercialization, Inc.	Recruiting	No outcome recorded
Phase 3	NCT04786574	Jul 2022 → Dec 2025	autosomal recessive polycystic kidney disease	Otsuka Pharmaceutical Development & Commercialization, Inc.	Withdrawn	No outcome recorded
Phase 3	NCT03255226	Mar 2018 → Jul 2021	congestive heart failure	Otsuka Pharmaceutical Co., Ltd.	Completed	No outcome recorded
Phase 3	NCT03048747	Mar 2017 → Mar 2019	inappropriate ADH syndrome	Otsuka Pharmaceutical Co., Ltd.	Completed	No outcome recorded
Phase 3	NCT02964273	Sep 2016 → Nov 2021	autosomal dominant polycystic kidney disease	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 3	NCT02020278	Apr 2016 → Oct 2017	—	Otsuka Pharmaceutical Development & Commercialization, Inc.	Terminated	No outcome recorded
Phase 3	NCT02012959	Sep 2015 → Jul 2017	—	Otsuka Pharmaceutical Development & Commercialization, Inc.	Terminated	No outcome recorded
Phase 3	NCT02251275	Oct 2014 → Nov 2018	autosomal dominant polycystic kidney disease	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 3	NCT02160145	May 2014 → Apr 2017	autosomal dominant polycystic kidney disease, chronic kidney disease	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 3	NCT01644331	Oct 2012 → Feb 2016	congestive heart failure	Duke University	Completed	No outcome recorded
Phase 3	NCT01618448	Jul 2012 → May 2014	pulmonary edema	Taiwan Otsuka Pharm. Co., Ltd	Completed	No outcome recorded
Phase 3	NCT01651156	Jul 2012 → Jul 2013	congestive heart failure	Otsuka Beijing Research Institute	Completed	No outcome recorded
Phase 3	NCT01556646	Apr 2011 → Jun 2013	cirrhosis of liver, hepatic encephalopathy	Hunter Holmes Mcguire Veteran Affairs Medical Center	Completed	No outcome recorded
Phase 3	NCT01280721	Nov 2010 → Aug 2014	autosomal dominant polycystic kidney disease	Otsuka Pharmaceutical Co., Ltd.	Completed	No outcome recorded
Phase 3	NCT01227512	Oct 2010 → May 2013	inappropriate ADH syndrome	Otsuka Pharmaceutical Development & Commercialization, Inc.	Terminated	No outcome recorded
Phase 3	NCT01349348	Oct 2010 → May 2012	cirrhosis of liver	Otsuka Beijing Research Institute	Completed	No outcome recorded
Phase 3	NCT01214421	May 2010 → Feb 2016	autosomal dominant polycystic kidney disease	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 3	NCT01114828	Feb 2010 → Oct 2011	cirrhosis of liver	Otsuka Pharmaceutical Co., Ltd.	Completed	No outcome recorded
Phase 3	NCT01050530	Dec 2009 → Feb 2012	cirrhosis of liver	Otsuka Pharmaceutical Co., Ltd.	Completed	No outcome recorded
Phase 3	NCT01048788	Dec 2009 → Aug 2011	cirrhosis of liver	Otsuka Pharmaceutical Co., Ltd.	Completed	No outcome recorded
Phase 3	NCT01022424	Nov 2009 → Jul 2014	autosomal dominant polycystic kidney disease	Otsuka Pharmaceutical Co., Ltd.	Completed	No outcome recorded
Phase 3	NCT00544869	Oct 2007 → Feb 2009	congestive heart failure	Otsuka Pharmaceutical Co., Ltd.	Completed	No outcome recorded
Phase 3	NCT00525265	Sep 2007 → Jan 2009	congestive heart failure	Otsuka Pharmaceutical Co., Ltd.	Completed	No outcome recorded
Phase 3	NCT00462670	Apr 2007 → Oct 2008	congestive heart failure	Otsuka Pharmaceutical Co., Ltd.	Completed	No outcome recorded
Phase 3	NCT00428948	Jan 2007 → Jan 2012	autosomal dominant polycystic kidney disease	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 3	NCT02449044	May 2004 → Oct 2009	—	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 3	NCT00201994	Nov 2003 → Jul 2005	—	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 3	NCT00071331	Sep 2003 → Jul 2006	congestive heart failure	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 3	NCT00072683	Apr 2003 → Dec 2005	inappropriate ADH syndrome, water intoxication	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 3	NCT01733134	—	heart failure	Maisel, Alan, M.D.	Withdrawn	No outcome recorded

Phase 413 trials
Phase 4	NCT03949894	Jul 2019 → May 2022	autosomal dominant polycystic kidney disease	Korea Otsuka Pharmaceutical Co., Ltd.	Completed	No outcome recorded
Phase 4	NCT02959411	Oct 2016 → Jun 2020	heart failure	University of Calgary	Terminated	No outcome recorded
Phase 4	NCT02666651	May 2016 → Jan 2020	symptomatic heart failure	Cardiology Research UBC	Unknown	No outcome recorded
Phase 4	NCT02606253	Feb 2016 → Sep 2018	heart failure	Vanderbilt University	Completed	No outcome recorded
Phase 4	NCT02476409	Jul 2015 → May 2021	congestive heart failure	University of North Carolina, Chapel Hill	Completed	No outcome recorded
Phase 4	NCT02183792	Dec 2014 → Feb 2018	heart failure	University of Southern California	Completed	No outcome recorded
Phase 4	NCT01973140	Nov 2013 → Dec 2015	—	Northwestern University	Completed	No outcome recorded
Phase 4	NCT02352285	Dec 2012 → Jan 2017	heart failure	Korea Otsuka Pharmaceutical Co., Ltd.	Terminated	No outcome recorded
Phase 4	NCT01292304	Mar 2012 → Dec 2014	cirrhosis of liver	University of Florida	Completed	No outcome recorded
Phase 4	NCT01890694	Mar 2012 → Mar 2015	—	NYU Langone Health	Terminated	No outcome recorded
Phase 4	NCT01439009	Sep 2011 → Mar 2014	heart failure	Otsuka Pharmaceutical Co., Ltd.	Completed	No outcome recorded
Phase 4	NCT01199198	May 2011 → Sep 2013	—	M.D. Anderson Cancer Center	Completed	No outcome recorded
Phase 4	NCT01346072	Apr 2011 → Feb 2014	heart failure	University of North Carolina, Chapel Hill	Completed	No outcome recorded

Phase not applicable6 trials
—	NCT05569655	Apr 2021 → Nov 2022	pulmonary arterial hypertension	Chinese Pulmonary Vascular Disease Research Group	Unknown	No outcome recorded
—	NCT02729662	Oct 2016 → Aug 2020	autosomal dominant polycystic kidney disease	Kyorin University	Unknown	No outcome recorded
—	NCT02538016	Oct 2016 → Dec 2018	cystinuria	Caleb Nelson	Completed	No outcome recorded
—	NCT02545114	Aug 2015 → Jul 2016	inappropriate ADH syndrome	Polderman, Kees, H., MD, PhD	Terminated	No outcome recorded
—	NCT01425125	Nov 2011 → Dec 2014	inappropriate ADH syndrome	NYU Langone Health	Withdrawn	No outcome recorded
—	NCT02084797	Jun → Oct 2011	—	Oakland University	Completed	No outcome recorded

Also used as a comparator or background therapy in 19 trials

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 24 trials
Phase 2	NCT03541447 Background	Dec 2018 → Dec 2021	autosomal dominant polycystic kidney disease	Mario Negri Institute for Pharmacological Research	Completed	No outcome recorded
Phase 2	NCT02527863 Comparator	Feb 2015 → Aug 2016	autosomal dominant polycystic kidney disease	Regional Hospital Holstebro	Completed	No outcome recorded
Phase 2	NCT02078973 Comparator	Mar 2014 → Jan 2016	—	Regional Hospital Holstebro	Completed	No outcome recorded
Phase 2	NCT01638663 Comparator	May 2012 → Mar 2014	cardiovascular disorder	Regional Hospital Holstebro	Completed	No outcome recorded
Phase 36 trials
Phase 3	NCT03764605 Comparator	Jan 2019 → Sep 2021	autosomal dominant polycystic kidney disease	Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari	Unknown	No outcome recorded
Phase 3	NCT03772041 Comparator	Jan 2019 → Jul 2020	congestive heart failure	Otsuka Pharmaceutical Co., Ltd.	Completed	No outcome recorded
Phase 3	NCT03803124 Comparator	Dec 2015 → Dec 2017	autosomal dominant polycystic kidney disease	Regional Hospital Holstebro	Completed	No outcome recorded
Phase 3	NCT02442674 Comparator	Nov 2015 → Jun 2017	—	Otsuka Pharmaceutical Development & Commercialization, Inc.	Withdrawn	No outcome recorded
Phase 3	NCT01584557 Comparator	Jun 2012 → Jul 2016	heart failure	Cardiovascular Clinical Sciences Inc	Completed	No outcome recorded
Phase 3	NCT00550459 Comparator	Aug 2007 → Feb 2009	—	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded

Phase 46 trials
Phase 4	NCT03596957 Comparator	Sep 2018 → Jun 2019	autosomal dominant polycystic kidney disease	Lisbet Brandi	Unknown	No outcome recorded
Phase 4	NCT02644616 Comparator	Nov 2014 → Dec 2016	heart failure, tricuspid valve insufficiency	Shanghai Chest Hospital	Completed	No outcome recorded
Phase 4	NCT01863511 Comparator	May 2013 → Dec 2015	heart failure	The Christ Hospital	Completed	No outcome recorded
Phase 4	NCT01716611 Comparator	Nov 2012 → Jan 2014	—	Konkuk University Medical Center	Unknown	No outcome recorded
Phase 4	NCT01663662 Comparator	Aug 2012 → Nov 2013	heart failure	University of Michigan	Withdrawn	No outcome recorded
Phase 4	NCT01552590 Comparator	Apr 2012	—	Korea Otsuka Pharmaceutical Co., Ltd.	Terminated	No outcome recorded

Phase not applicable3 trials
—	NCT04331132 Comparator	Dec 2021 → Jun 2023	heart failure	Gia Dinh People Hospital	Unknown	No outcome recorded
—	NCT05060523 Background	Sep 2021 → Sep 2022	cirrhosis of liver	Institute of Liver and Biliary Sciences, India	Unknown	No outcome recorded
—	NCT03254108 Comparator	Nov 2017 → Apr 2018	congestive heart failure	Otsuka Pharmaceutical Co., Ltd.	Completed	No outcome recorded

Press releases naming this drug 33 releases

Date	Issuer	Release
2022-06-17	Otsuka Pharmaceutical Factory, Inc.	Otsuka Pharmaceutical Factory launches a vasopressin V₂-receptor antagonist "Tolvaptan OD tablets 7.5 mg Otsuka" otsukakj.jp ↗
2019-11-27	Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka Launches New SAMSCA Formulation in Japan: SAMSCA OD Tablets® otsuka.co.jp ↗
2019-08-28	Otsuka Pharmaceutical Development & Commercialization, Inc.	Approval for the Additional Formulation of Samsca OD Tablets in Japan® otsuka.co.jp ↗
2018-04-25	Otsuka Pharmaceutical Development & Commercialization, Inc.	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 ↗
2018-04-24	Otsuka Pharmaceutical Development & Commercialization, Inc.	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 ↗
2017-11-09	Otsuka Pharmaceutical Development & Commercialization, Inc.	U.S. FDA Accepts Otsuka's Resubmission to Support a Regulatory Review of Tolvaptan in the Treatment of ADPKD otsuka.co.jp ↗
2017-11-08	Otsuka Pharmaceutical Development & Commercialization, Inc.	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.	Otsuka Announces Phase 3 Results for Tolvaptan in Patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) otsuka.co.jp ↗
2017-11-04	Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka Announces Phase 3 Results for Tolvaptan in Patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) otsuka-us.com ↗
2017-10-27	Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka To Host Web Briefing on Tolvaptan Phase 3 Trial Results In Polycystic Kidney Disease otsuka-us.com ↗
2017-05-30	Otsuka Pharmaceutical Development & Commercialization, Inc.	Additional Formulation of Samsca Granules 1% Available in Japan® otsuka.co.jp ↗
2017-05-22	Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka Announces Results of Phase 3 Data on Tolvaptan Under Development for ADPKD in U.S. otsuka.co.jp ↗
2017-05-21	Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka Announces Results of Phase 3 Data on Tolvaptan Under Development for ADPKD in U.S. otsuka-us.com ↗
2017-03-16	Otsuka Pharmaceutical Development & Commercialization, Inc.	Approval for the Additional Formulation of Samsca Granules 1% in Japan® otsuka.co.jp ↗
2015-05-28	Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka's JINARC the First-Ever Treatment Approved in Europe for Adults Living with ADPKD, a Chronic Genetic Kidney Disease® otsuka.co.jp ↗
2015-02-27	Otsuka Pharmaceutical Development & Commercialization, Inc.	CHMP Recommends JINARC (Tolvaptan) for Approval in EU: The First Pharmaceutical Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD)® otsuka.co.jp ↗
2014-06-11	Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka Pharmaceutical Initiates Phase 3 Clinical Trial of Tolvaptan in Patients with Autosomal Dominant Polycystic Kidney Disease otsuka-us.com ↗
2014-05-23	Otsuka Pharmaceutical Development & Commercialization, Inc.	Launch in Japan of Samsca 30 mg Tablet Formulation for Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD), an Orphan Disease otsuka.co.jp ↗
2014-03-24	Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka Pharmaceutical's Samsca Approved in Japan as the World's First Drug Therapy for ADPKD, a Rare Kidney Disease® otsuka.co.jp ↗
2013-12-27	Otsuka Pharmaceutical Development & Commercialization, Inc.	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 ↗
2013-08-30	Otsuka Pharmaceutical Development & Commercialization, Inc.	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 ↗
2013-08-06	Otsuka Pharmaceutical Development & Commercialization, Inc.	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 ↗
2013-08-05	Otsuka Pharmaceutical Development & Commercialization, Inc.	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 ↗
2013-06-03	Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka Pharmaceutical Submits New Drug Application in Japan for Tolvaptan for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD) otsuka.co.jp ↗
2013-06-03	Otsuka Pharmaceutical Development & Commercialization, Inc.	Vasopressin V2 Receptor Antagonist Samsca 7.5mg Tablets To Be Launched in Japan on June 4 - Additional Choice of Dose for the Treatment of Volume Overload in Patients with Heart Failure® otsuka.co.jp ↗
2013-04-12	Otsuka Pharmaceutical Development & Commercialization, Inc.	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.	7.5mg Tablets Additionally Approved - Samsca, Vasopressin V2 Receptor Antagonist® otsuka.co.jp ↗
2012-11-05	Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka's Investigational Compound for Autosomal Dominant Polycystic Kidney Disease (ADPKD), Tolvaptan, Meets Primary Endpoint in a Phase III Clinical Trial otsuka.co.jp ↗
2012-08-01	Otsuka Pharmaceutical Development & Commercialization, Inc.	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 ↗
2010-12-10	Otsuka Pharmaceutical Development & Commercialization, Inc.	World's First Aquaretic Agent for the Treatment of Volume Overload in Patients with Heart Failure Samsca Tablets 15mg (tolvaptan), Vasopressin V-Receptor Antagonist, to be Launched in Japan on December 14®2 otsuka.co.jp ↗
2010-10-27	Otsuka Pharmaceutical Development & Commercialization, Inc.	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.	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 ↗
2009-05-21	Otsuka Pharmaceutical Development & Commercialization, Inc.	FDA Approves SAMSCA (tolvaptan), The First and Only Oral Vasopressin Antagonist to Treat Patients with Clinically Significant Hypervolemic and Euvolemic Hyponatremia™ otsuka.co.jp ↗

Evidence & citations 12 cited values

Every value below carries the sentence it was read from. 102 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 ↗ 88 “single dose of 15mg Tolvaptan tablet with no feeding.” NCT07166796 ↗ “OPC-41061 （Tolvaptan)” NCT00544869 ↗ “OPC-41061(Tolvaptan)” NCT00234104 ↗ “OPC-41061(Tolvaptan)” NCT00525265 ↗ “OPC-41061(Tolvaptan)” NCT00462670 ↗ NCT01507727 ↗ NCT01280721 ↗ NCT01644331 ↗ NCT04786574 ↗ NCT01663662 ↗ NCT03255226 ↗ NCT05060523 ↗ NCT02160145 ↗ NCT03772041 ↗ NCT02959411 ↗ NCT03048747 ↗ NCT00132886 ↗ NCT01346072 ↗ NCT04782258 ↗ NCT02729662 ↗ NCT00071331 ↗ NCT03910231 ↗ NCT02078973 ↗ NCT01863511 ↗ NCT01716611 ↗ NCT05569655 ↗ NCT01651156 ↗ NCT01227512 ↗ NCT00072683 ↗ NCT02352285 ↗ NCT01973140 ↗ NCT02666651 ↗ NCT02012959 ↗ NCT01584557 ↗ NCT02173288 ↗ NCT00428948 ↗ NCT01556646 ↗ NCT02527863 ↗ NCT07166887 ↗ NCT02020278 ↗ NCT01552590 ↗ NCT00201994 ↗ NCT02646540 ↗ NCT00664014 ↗ NCT02442674 ↗ NCT01199198 ↗ NCT01733134 ↗ NCT03764605 ↗ NCT02183792 ↗ NCT03254108 ↗ NCT02251275 ↗ NCT02545114 ↗ NCT01451827 ↗ NCT07166783 ↗ NCT01425125 ↗ NCT03931369 ↗ NCT03596957 ↗ NCT03803124 ↗ NCT02606253 ↗ NCT00413777 ↗ NCT01210560 ↗ NCT01638663 ↗ NCT00550459 ↗ NCT06506994 ↗ NCT02644616 ↗ NCT01214421 ↗ NCT02476409 ↗ NCT01261481 ↗ NCT02096965 ↗ NCT01439009 ↗ NCT01292304 ↗ NCT02964273 ↗ NCT01359462 ↗ NCT00043771 ↗ NCT01386372 ↗ NCT00043758 ↗ NCT02538016 ↗ NCT03541447 ↗ NCT02009878 ↗ NCT01890694 ↗ NCT01618448 ↗ NCT01349348 ↗ NCT03949894 ↗ NCT01014416 ↗ NCT04331132 ↗ NCT01349335 ↗ NCT02449044 ↗ NCT01336972 ↗
Known as	Jinarc	ChEMBL registry synonym — accepted as the source's own label CHEMBL344159 ↗
Known as	Jynarque	ChEMBL registry synonym — accepted as the source's own label CHEMBL344159 ↗
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 ↗ 18 “OPC41061 (15 mg) orally disintegrating tablet is administered with water.” NCT02994394 ↗ “Tolvaptan (OPC-41061)” NCT04786574 ↗ “Tolvaptan (OPC-41061)” NCT02160145 ↗ NCT01048788 ↗ NCT02994394 ↗ NCT02331680 ↗ NCT01022424 ↗ NCT00841568 ↗ NCT00234104 ↗ NCT01684202 ↗ NCT00462670 ↗ NCT01895322 ↗ NCT01876381 ↗ NCT00544869 ↗ NCT01050530 ↗ NCT00479336 ↗ NCT00525265 ↗ NCT01114828 ↗
Known as	OPC-41061(TOLVAPTAN)	ChEMBL registry synonym — accepted as the source's own label CHEMBL344159 ↗
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 ↗
Known as	Tolvaptan accord	ChEMBL registry synonym — accepted as the source's own label CHEMBL344159 ↗
Action	Inhibit	“vasopressin V2 receptor antagonism with tolvaptan” PMID 17543634 ↗ May 2007 1 “Vasopressin V2 receptor antagonist” CHEMBL344159 ↗
Modality	Small molecule	— CHEMBL344159 ↗
Route	Oral	“oral tolvaptan” PMID 17543634 ↗ May 2007
Target	AVP	“tolvaptan, an oral AVP inhibitor” NCT00201994 ↗
Target	AVPR2	“Vasopressin V2 receptor antagonist” CHEMBL344159 ↗