Primary objective: To investigate the in vivo pharmacokinetic characteristics of tolvaptan tablets (specification: 15 mg) produced by Shijiazhuang Huaxin Pharmaceutical Co., Ltd. and tolvaptan tablets (specification: 15 mg) produced by Zhejiang Otsuka Pharmaceutical Co., Ltd. through a bioequivalence study of oral administration of tolvaptan tablets, and to evaluate the bioequivalence of the two preparations. Secondary objective: To evaluate the safety of the test and reference preparations of single-dose oral tolvaptan tablets in healthy Chinese subjects.

Start Date24 Aug 2024

Sponsor / Collaborator

Shijiazhuang Huaxin Pharmaceutical Co., Ltd.

NCT06506994 / Not yet recruitingPhase 1

An Open Label, Tolvaptan-controlled Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Multiple Ascending Dose of HRS-9057 in Heart Failure With Volume Overload

The study is an open-label, Tolvaptan-controlled Phase I study to evaluate the safety, tolerability, PK/PD profile and efficacy of HRS-9057 in the treatment of heart failure with volume overload. A total of 24 subjects who experience volume overload due to heart failure despite diuretic treatment will be enrolled in the study and receive HRS-9057 injection or Tolvaptan tablets.

Start Date15 Jul 2024

Sponsor / Collaborator

Fujian Suncadia Pharmaceuticals Co Ltd.

100 Clinical Results associated with Tolvaptan

100 Translational Medicine associated with Tolvaptan

100 Patents (Medical) associated with Tolvaptan

1,374

Literatures (Medical) associated with Tolvaptan

01 Dec 2024·RENAL FAILURE

Effectiveness of tolvaptan on renal replacement therapy in patients with autosomal dominant polycystic kidney disease: a retrospective cohort study from the TriNetX global collaborative network.

Article

Author: Wu, Ming-Ju ; Tsai, Shang-Feng ; Chen, Cheng-Hsu

BACKGROUND AND HYPOTHESIS:

Autosomal Dominant Polycystic Kidney Disease (ADPKD) is a major genetic contributor to end-stage kidney disease (ESKD). Current evidence on tolvaptan primarily focuses on slowing estimated glomerular filtration rate (eGFR) decline and kidney volume growth. However, direct confirmation of its effectiveness in reducing the need for hemodialysis in ESKD remains limited.

METHODS:

We included ADPKD patients aged ≥18 years using TriNetx data from Sep 2, 2018, to Sep 3, 2023. Propensity score matching (PSM) ensured baseline comparability (standardized mean difference (SMD) <0.1). Hazard ratios (HRs) with 95% confidence intervals (CIs) evaluated outcomes, and subgroup analyses were performed.

RESULTS:

After 1:1 PSM, both groups comprised 673 patients. The average age was 45, with generally good health (3-5% diabetes, 2-3% ischemic heart disease). Baseline eGFR averaged ∼55 ml/min/1.732m². Post-matching, all SMDs were <0.1, indicating successful matching. Tolvaptan users exhibited lower eGFR (51.45 ± 30.09 vs. 57.37 ± 33.65, p < 0.001) and higher risk of stage 4-CKD (HR: 2.436, 95% CI:1.649, 3.599) compared to non-users. However, tolvaptan users showed significantly reduced chances of initiating hemodialysis (HR:0.362, 95%CI:0.176, 0.745), experiencing urinary tract infections (HR:0.581, 95%CI:0.354, 0.956), and all-cause mortality (HR:0.355, 95% CI:0.180, 0.700). Kaplan-Meier curves for hemodialysis initiation indicated higher survival rates among tolvaptan users across age and number of medication refill subgroups.

CONCLUSIONS:

This real-world study, employing precise matching, reveals tolvaptan's role in reducing hemodialysis initiation risk in ADPKD, despite initial hemodynamic-induced lower eGFR.

01 Nov 2024·EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY

Prognostic effect of a vasopressin V2 receptor antagonist in acute congestive heart failure patients with hypoperfusion, the wet–cold pattern

Article

Author: Matsushita, Kenichi ; Yamamoto, Yoshiya ; Takayama, Morimasa ; Shiraishi, Yasuyuki ; Harada, Kazumasa ; Miyamoto, Takamichi ; Yoshino, Hideaki ; Nagatomo, Yuji ; Yamamoto, Takeshi ; Iida, Kiyoshi ; Nagao, Ken

PURPOSE:

This study investigated whether the oral vasopressin V₂ receptor antagonist tolvaptan has beneficial effects on mortality in real-world congestive heart failure (CHF) patients with hypoperfusion (i.e. the wet-cold pattern), from the viewpoint of cardiorenal syndrome.

METHODS:

Data on 5511 consecutive CHF patients were extracted from the Tokyo CCU Network data registry. Congestion and hypoperfusion were defined by Nohria-Stevenson clinical profiles at the time of hospitalization. Propensity scores for tolvaptan use were calculated for each patient and used to assemble two matched cohorts of patients receiving tolvaptan or not in the CHF with and without hypoperfusion groups.

RESULTS:

Of the entire study cohort, 1073 patients (19%) had CHF with hypoperfusion (i.e. the wet-cold pattern). In-hospital mortality was significantly higher for CHF patients with than without hypoperfusion (log-rank, P < 0.001). The rate of tolvaptan use did not differ significantly between CHF patients with and without hypoperfusion (15% vs. 14%, respectively; P = 0.7848). In the propensity-matched CHF with hypoperfusion cohort, there was a significant association between the use of tolvaptan and a reduction in in-hospital mortality (log-rank, P = 0.0052). Conversely, in the matched CHF without hypoperfusion cohort, tolvaptan use was not associated with in-hospital mortality (log-rank, P = 0.4417).

CONCLUSION:

There was a significant association between the use of tolvaptan and a reduction in in-hospital mortality in CHF patients with, but not without, hypoperfusion. These findings hint at possible individualized therapies for patients with CHF.

01 Oct 2024·Clinical Kidney Journal

Tolvaptan and the role of kidney aquaporin-2 abundance in managing volume overload in patients with CKD

Article

Author: Wang, Bin ; Wang, Feng-mei ; Liu, Hong ; Li, Xiao-min ; Yang, Yan ; Zhang, Xiao-liang ; Tang, Ri-ning ; Liu, Bi-cheng ; Yan, Yu

ABSTRACT:

Objective:

This retrospective study evaluated tolvaptan's efficacy, safety, and predictive indicators in managing volume overload in chronic kidney disease (CKD) patients.

Methods:

CKD patients with volume overload, treated with loop diuretics alone or with tolvaptan at Zhongda Hospital, Southeast University, from 1 March 2022 to 31 December 2023, were included. Patients were divided into loop diuretic (Group C) and loop diuretic combined with tolvaptan (Group T) cohorts. Primary outcomes included volume control, changes in weight, urine output, and laboratory parameters within 1 week post-medication. Adverse events such as hypernatremia and hyperkalemia, etc., were recorded. We further conducted immunohistochemical staining of renal biopsy tissues to investigate the roles of aquaporin-2 (AQP2) in the collecting duct and plasma albumin in predicting the efficacy of tolvaptan.

Results:

Of 174 CKD patients with volume overload, 108 (67.07%) were male. Group C and Group T each comprised 87 patients. At baseline, no significant differences in urine output and weight were noted. By day 3, Group T exhibited a greater increase in urine output (P < .001) and weight reduction (P < .001). At day 7, Group T maintained more significant diuretic effects (P < .001). More Group C patients required ultrafiltration therapy (P = .040). Adverse event rates did not significantly differ. Notably, AQP2 expression in the collecting duct may predict tolvaptan responsiveness, while plasma albumin did not affect efficacy.

Conclusion:

Tolvaptan showed efficacy and safety in managing volume overload in CKD patients. The expression of AQP2 in the collecting duct could predict tolvaptan's efficacy.This study protocol was approved by the Ethics Committee of Zhongda Hospital Affiliated to Southeast University (Approval No. 2023ZDSYLL180-P01, Clinical Trial Registration No. ChiCTR2300075274, Trial Registration Link: https://www.chictr.org.cn/guide.html).

News (Medical) associated with Tolvaptan

01 Aug 2024

·www.globenewswire.com

Otsuka Pharmaceutical to Acquire Jnana Therapeutics Inc.

- Transaction Includes JNT-517, a Potential First-In-Class Oral Treatment for Phenylketonuria (PKU) - - Expands Specialty and Autoimmune Portfolios and Drug Discovery Technologies - TOKYO and BOSTON, Aug. 01, 2024 (GLOBE NEWSWIRE) -- Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Jnana Therapeutics Inc. (Jnana) today announced that they have entered into a definitive merger agreement pursuant to which Otsuka will acquire Jnana, making it a wholly owned subsidiary through Otsuka’s 100-percent owned subsidiary, Otsuka America, Inc. (OAI). The acquisition is expected to be completed in the third quarter of fiscal 2024, subject to customary closing conditions. Based on the terms of the agreement, Otsuka will pay USD $800 million to the shareholders of Jnana upon completion of the acquisition, as well as up to an additional USD $325 million in development and regulatory milestones. 1．Reasons for the acquisition Jnana’s novel approach to drug discovery is enabled by RAPID – the company’s next-generation chemoproteomics platform designed to discover medicines for highly validated but challenging-to-drug targets. The platform leverages a high-throughput, binding-based screening approach that is inherently flexible, enabling the discovery of binding sites across the surface of a target protein and the identification of small molecules that elicit diverse pharmacologies. Jnana has used RAPID to successfully identify first-in-class compounds and address a range of historically challenging-to-drug target classes, including solute carriers, transcription factors, and signaling scaffold proteins. Jnana pursues drug discovery based on concepts that are complementary to those of Astex Pharmaceuticals, a subsidiary of Otsuka based in Cambridge, UK. While Jnana's RAPID platform is not limited to any specific therapeutic area, the company has built a unique competitive position by concentrating on PKU, a rare inherited metabolic disorder in which phenylalanine accumulates to abnormally high levels in the blood, and autoimmune diseases, where small molecule drug discovery has been challenging. Jnana’s technology successfully generated JNT-517, an allosteric small molecule inhibitor of SLC6A19, an SLC (solute carrier) that regulates amino acid reabsorption in the kidney. JNT-517 has the potential to become a first-in-class oral treatment for PKU, as it has been shown to be effective, well-tolerated, and safe in a Phase 1b/2 study. A majority of the PKU population is not effectively treated with existing therapies, and JNT-517 is an approach that could address individuals of all ages across the spectrum of mild to severe disease. In the autoimmune disease field, the company is pursuing small molecule drug discovery for highly validated, but challenging-to-drug, targets such as interferon regulatory factor 3 (IRF3), a master transcription factor for the production of interferon. Otsuka has advanced contributions to patients with a wide range of rare diseases, not only in the renal area with JINARC (approved for autosomal dominant polycystic kidney disease), sibeprenlimab (IgA nephropathy), and voclosporin (lupus nephritis), but also by adding new specialty drugs such as donidalorsen (hereditary angioedema). Additionally, through Visterra, a Boston-based company that Otsuka acquired in 2018, Otsuka is advancing research and development in the autoimmune field using antibody drug technology, while also expanding its drug discovery platform. Makoto Inoue, president and representative director of Otsuka Pharmaceutical commented, "I am gratified that Otsuka has entered into an agreement with Jnana. The addition of Jnana's drug discovery technology and small molecule pipeline in PKU and autoimmune diseases will strengthen our R&D in the Boston area of the U.S., one of the most important bioclusters in the world, and in a combined form will have a synergistic effect on Otsuka Pharmaceutical's global expansion.” Joanne Kotz, Ph.D., CEO and co-founder of Jnana, commented, "This transaction recognizes the Jnana team’s accomplishments since the founding of the company, which include creating RAPID – a world-class small molecule drug discovery platform. Leveraging our platform, the team discovered JNT-517, a potential first-in-class oral medicine for the treatment of PKU, and has demonstrated positive clinical proof of concept for JNT-517 in individuals with PKU. We are excited to join Otsuka with our shared goal of developing transformative therapies for patients and look forward to advancing JNT-517 into a registrational study in 2025 and continuing to progress our pipeline of innovative oral medicines for autoimmune diseases." 2．Outline of the acquisition Upon completion of the acquisition, Jnana will operate as a wholly owned subsidiary of Otsuka in Boston and will continue its research and development. The acquisition will be implemented by merging a special purpose company, established under OAI for this acquisition, into Jnana Therapeutics, with Jnana remaining as the surviving company. Existing shareholders of Jnana will be paid cash as consideration for this merger. Although the Boards of Directors of both Otsuka and Jnana have approved this acquisition, the execution of this acquisition may require the approval of Jnana's shareholders and the fulfillment of conditions under U.S. antitrust laws. After completion of necessary procedures, we aim to complete the acquisition during the third quarter of 2024. 3．Additional information about Otsuka (https://www.otsuka.co.jp/en/) Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: Otsuka–people creating new products for better health worldwide. Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.In pharmaceuticals, Otsuka is a leader in the challenging areas of mental, renal, and cardiovascular health and has additional research programs in oncology and on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does. 4．Additional information about Jnana (https://www.jnanatx.com/) Jnana Therapeutics is a clinical-stage biotechnology company leveraging its next-generation RAPID chemoproteomics platform to discover medicines for highly validated, challenging-to-drug targets to treat diseases with high unmet needs. Jnana is focused on developing first- and best-in-class therapies to treat a wide range of diseases, including rare diseases and immune-mediated diseases. Jnana’s lead program, JNT-517, which targets an allosteric site on the phenylalanine transporter SLC6A19, is a potential first-in-class oral approach for the treatment of PKU, a rare genetic metabolic disease. Located in Boston, Jnana brings together scientific leaders in small molecule drug discovery and development, a highly experienced management team, and the backing of leading life science investors Bain Capital Life Sciences, RA Capital Management, Polaris Partners, Versant Ventures, Avalon Ventures, Pfizer Ventures, and AbbVie Ventures. 5．Advisors Centerview Partners LLC acted as financial advisor to Jnana and Latham & Watkins LLP acted as its legal advisor.

AcquisitionDrug Approval

28 May 2024

·www.prnewswire.com

Rege Nephro CO., Ltd. Announces Patient Enrollment for Phase II Clinical Trial of Tamibarotene for ADPKD

KYOTO, Japan, May 28, 2024 /PRNewswire/ -- Rege Nephro CO., Ltd. () has announced that patient enrollment began in April for the second stage of its Phase II clinical trial of tamibarotene as a developmental product for the treatment of autosomal dominant polycystic kidney disease (ADPKD) under the code RN-014. After reviewing all available safety data from the first stage, which started in December of last year, the decision was made to advance to the second stage. The company aims to complete patient enrollment by the end of 2024. Public Clinical Trial Information jRCT (Japan Registry of Clinical Trials): A system for the submission and publication of clinical research () ClinicalTrials.gov: A public website provided by the U.S. National Library of Medicine () Tolvaptan is the only approved drug for the treatment of ADPKD. Since the launch of tolvaptan, pharmaceutical companies worldwide have been developing numerous clinical trials of new drugs to treat ADPKD, but most of these drugs have already been discontinued due to inefficacy, highlighting the strong need for new treatment options. RN-014 is currently at the most advanced stage of development among the drugs in development for patients with ADPKD. About ADPKD Autosomal dominant polycystic kidney disease (ADPKD) is the most common hereditary cystic kidney disease. It is characterized by the gradual development and enlargement of multiple cysts in both kidneys, leading to progressive renal dysfunction. Cysts can also occur in the liver and pancreas, and vascular abnormalities throughout the body are common, including high blood pressure, cerebral aneurysms, and heart valve abnormalities. Currently, tolvaptan, which inhibits cyst growth, is the only approved treatment for ADPKD, but there is no curative treatment available. About RN-014 Tamibarotene, under development for ADPKD, is a retinoic acid receptor (RAR) agonist expected to potently inhibit cyst formation and improve renal function. The clinical trial dose identified in multiple mouse model experiments is 4mg/day, and its safety has been confirmed in past studies. With advice from the Pharmaceuticals and Medical Devices Agency (PMDA), the Phase II clinical trial began in December 2023. This trial includes a pharmacokinetic (PK) phase and a randomization phase. Various safety measures have been established, including phased patient enrollment, periodic independent safety monitoring, strict criteria for dose reduction and discontinuation of the investigational drug, and criteria for discontinuation of the entire trial. About Rege Nephro CO., Ltd. Rege Nephro CO., Ltd. is a clinical-stage biotech company utilizing induced pluripotent stem cell (iPSC)-based technology from the Center for iPS Cell Research and Application (CiRA), Kyoto University. It is developing therapeutics and cell therapy for kidney, liver, and pancreas diseases. Media Inquiries: Katsuhisa Yamaguchi, CFO Rege Nephro CO., Ltd. TEL: 075-744-6858 E-mail: [email protected] SOURCE Rege Nephro CO., Ltd.

Phase 2Drug ApprovalCell Therapy

08 Apr 2024

·www.sciencedaily.com

Scientists grow 'mini kidneys,' revealing new insights into metabolic defects and potential therapy for polycystic kidney disease

Scientists have successfully grown 'mini kidneys' in the lab and grafted them into live mice, revealing new insights into the metabolic defects and a potential therapy for polycystic kidney disease. Scientists at Nanyang Technological University, Singapore (NTU Singapore) have successfully grown 'mini kidneys' in the lab and grafted them into live mice, revealing new insights into the metabolic defects and a potential therapy for polycystic kidney disease. 'Mini kidneys,' or kidney organoids, are kidney-like structures grown in the lab using stem cells. In the study led by NTU's Lee Kong Chian School of Medicine (LKCMedicine), researchers grew the organoids using skin cells derived from patients with polycystic kidney disease (PKD), a prevalent form of genetic condition that affects 1 in 1000 individuals across all ethnicities.* People with PKD often progress to end-stage kidney disease between their 50s and 60s, with the standard treatment options available being dialysis or a kidney transplant. However, dialysis significantly compromises a patient's quality of life, while a transplanted kidney can be challenging to acquire. One other option is the Food and Drug Administration (FDA) approved drug Tolvaptan, which is very costly and has severe side effects on the liver. To address the need for more effective treatment for PKD patients, the NTU research team sought to better understand the disease by engrafting their newly developed mini kidneys into mice. Previous studies were conducted on mini kidneys grown in a dish, which could only partly mimic the kidney structure and function. The NTU scientists engrafted the mini kidneys into live mice to comprehensively replicate the pathological features of kidney disease, including blood flow, fluid movement (tubular fluid) and cellular communication with other organs. Lead investigator Assistant Professor Xia Yun at LKCMedicine said, "Engrafting the kidney organoid in mice provided us with a physiologically sophisticated approach to studying polycystic kidney disease as we were able to successfully emulate critical disease characteristics similar to those observed in human kidney patients." Critical disease characteristics included abnormalities like the spontaneous formation of cysts in the kidneys and the subsequent damage to its tiny tubes. In their study, reported in the scientific journal Cell Stem Cell, the NTU research team said that they believed their engrafted mini kidneys were high quality because cysts sustained without extra stress stimulation or chemicals, even after they were removed from the live mice for further investigations in a dish. In contrast, previous kidney organoids grown in a dish cannot form cysts without stress stimulation. Co-investigator Assistant Professor Foo Jia Nee at LKCMedicine said, "The similarity between the disease manifestation observed in our engrafted mini kidney model and the real-life experiences of polycystic kidney disease patients suggest that growing kidney organoids and engrafting them into live mice could be beneficial in studying the disease and a useful tool to test new treatments." Metabolic defects in polycystic kidney disease Scientists have long known that abnormalities in a structure on kidney cells, or the primary cilium, cause cysts to form in kidneys. However, tests to understand the regulatory mechanism and relationship between the primary cilium and cell metabolism (autophagy) in live mice with PKD, have not been possible until now. By studying the development of PKD in live mice and testing cellular pathways, researchers found evidence that boosting autophagy could reduce the severity of cysts in the mini kidney. After establishing that boosting autophagy could reduce cysts, the NTU scientists shortlisted 22 drugs known for their effects on cell metabolism and tested them in the lab. Results showed that minoxidil, a clinical drug widely used to cure hypertension and hair loss, effectively reduced cyst formation in the novel mouse model. Asst Prof Xia Yun said, "Our study has demonstrated how cysts in polycystic diseased kidneys can be reduced by boosting autophagy, suggesting that this could be a promising treatment for PKD. Moreover, the proven clinical safety of minoxidil may allow it to be quickly re-purposed to treat PKD patients in clinic. However, more research will be needed to establish this potential." Commenting as an independent expert, Associate Professor Ng Kar Hui, Senior Consultant, Division of Paediatric Nephrology, Dialysis and Renal Transplantation, Department of Paediatrics, Khoo Teck Puat -- National University Children's Medical Institute, National University Hospital, said, "Polycystic kidney disease is one of the biggest causes of chronic kidney diseases among adults. An effective treatment may potentially ameliorate the rising numbers of people with kidney failure in Singapore. The establishment of such models in live organisms brings us one step closer to finding more treatment options. In future studies, the NTU team will test the efficacy of minoxidil and adapt the mini kidney models to investigate other burgeoning kidney diseases without a strong genetic underpinning, such as diabetic kidney disease. * Harris, P.C., and Torres, V.E. (2009). Polycystic kidney disease. Annual Review of Medicine. Volume 60, 321-337.

100 Deals associated with Tolvaptan

External Link

KEGG	Wiki	ATC	Drug Bank
D01213	Tolvaptan	C03XA01	DB06212

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Ascites	JP	Otsuka Pharmaceutical Co., Ltd.	28 Feb 2017
Polycystic Kidney, Autosomal Dominant	JP	Otsuka Holdings Co., Ltd.	24 Mar 2014
Edema, Cardiac	JP	Otsuka Pharmaceutical Co., Ltd.	05 Jan 2011
Edema	JP	Otsuka Holdings Co., Ltd.	27 Oct 2010
Inappropriate ADH Syndrome	EU	Otsuka Pharmaceutical Co., Ltd.	02 Aug 2009
Inappropriate ADH Syndrome	IS	Otsuka Pharmaceutical Co., Ltd.	02 Aug 2009
Inappropriate ADH Syndrome	LI	Otsuka Pharmaceutical Co., Ltd.	02 Aug 2009
Inappropriate ADH Syndrome	NO	Otsuka Pharmaceutical Co., Ltd.	02 Aug 2009
Hyponatremia	US	Otsuka Pharmaceutical Co., Ltd.	19 May 2009

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Polycystic Kidney, Autosomal Recessive	Phase 3	US	Otsuka Pharmaceutical Development & Commercialization, Inc.	01 Jul 2022
Polycystic Kidney, Autosomal Recessive	Phase 3	BE	Otsuka Pharmaceutical Development & Commercialization, Inc.	01 Jul 2022
Polycystic Kidney, Autosomal Recessive	Phase 3	DE	Otsuka Pharmaceutical Development & Commercialization, Inc.	01 Jul 2022
Polycystic Kidney, Autosomal Recessive	Phase 3	PL	Otsuka Pharmaceutical Development & Commercialization, Inc.	01 Jul 2022
Polycystic Kidney, Autosomal Recessive	Phase 3	ES	Otsuka Pharmaceutical Development & Commercialization, Inc.	01 Jul 2022
Polycystic Kidney, Autosomal Recessive	Phase 3	GB	Otsuka Pharmaceutical Development & Commercialization, Inc.	01 Jul 2022
Volume overload	Phase 3	JP	Otsuka Pharmaceutical Co., Ltd.	07 Mar 2018
Chronic Kidney Diseases	Phase 3	US	Otsuka Pharmaceutical Development & Commercialization, Inc.	01 May 2014
Chronic Kidney Diseases	Phase 3	AR	Otsuka Pharmaceutical Development & Commercialization, Inc.	01 May 2014
Chronic Kidney Diseases	Phase 3	AU	Otsuka Pharmaceutical Development & Commercialization, Inc.	01 May 2014

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03255226 (CTgov)	Phase 3	Volume overload \| Heart Failure	60	Tolvaptan	yexavdhiln(smtqxhbcsg) = ypwwkdnsnj bajehvhdmi (wofcncorqj, ojtqoximth - ctevxbhbwu) View more	-	23 Aug 2024
AASLD2023	Not Applicable	Liver Cirrhosis neutrophil gelatinase-associated lipocalin (uNGAL)	86	Tolvaptan	kkxeyhmrhy(gafxlfmxni) = alogfungrf uyygtmfdsm (mcznvcvpms ) View more	-	10 Nov 2023
Pubmed \| ESC Heart Fail	Not Applicable	Heart Failure	-	Tolvaptan use	oqzwjqgztj(zfelmcuibw) = prklcsghaw pzrbozevbn (eipfjnpyhq, 15 - 34) View more	-	01 Oct 2023
				No tolvaptan use	oqzwjqgztj(zfelmcuibw) = ovzfftbyym pzrbozevbn (eipfjnpyhq, 11 - 21) View more
ESC2023	Not Applicable	Heart Failure	846	tolvaptan	xjfxxdvakh(ulswujrxyg) = wirxhbxitg hzbvkqoonm (iwvcmoqxqj ) View more	-	27 Aug 2023
Pubmed \| BMC Nephrol	Not Applicable	Polycystic Kidney, Autosomal Dominant	-	Tolvaptan	sdrknbanng(mwckbyniwg) = iqwaxxoxlx uqqpdosljb (qdlklwpzgq ) View more	-	22 Jun 2023
				Placebo	sdrknbanng(mwckbyniwg) = guwhaqjqgv uqqpdosljb (qdlklwpzgq ) View more
NCT02964273 (#3034, ERA2023)	Phase 3	Polycystic Kidney, Autosomal Dominant	83	Tolvaptan	zoricjewxt(wdzzknsgzv) = 12%, 31% zfpdkptjlz (rqqejshkon ) View more	Positive	14 Jun 2023
				Placebo
#5783 (ERA2023)	Not Applicable	Polycystic Kidney, Autosomal Dominant	523	Tolvaptan	tcnvnvjwnn(xvgpphhugi) = 51% qvkkkqafsz (zsltfnnncn ) View more	Positive	14 Jun 2023
				No Tolvaptan
#4377 (ERA2023)	Not Applicable	Polycystic Kidney, Autosomal Dominant	75	Tolvaptan 45/15 mg	uspsybgrjw(rqmrufqwxy) = A significant increase (p< 0.0001) in 24-h urine volume (138%) occurred only immediately after therapy initiation with no further significant increase during updosing in the complete and longitudinal cohort cgvyiqreed (lmdzooyfhp ) View more	Positive	14 Jun 2023
				Tolvaptan 60/30 mg
NCT02160145 \| NCT00413777 \| NCT01885559 \| NCT01430494 \| NCT01336972 \| NCT02251275 \| NCT01214421 (REPRISE, Pubmed)	Not Applicable	Polycystic Kidney, Autosomal Dominant	-	Tolvaptan	iayvnvajij(dozgeqttqh) = hxmudxeqxy qcyiwwejdf (hageipsttv )	-	01 Jun 2023
				Non-tolvaptan standard of care	iayvnvajij(dozgeqttqh) = lbwpdgfbuq qcyiwwejdf (hageipsttv )
NCT03541447 (TOOL, Pubmed)	Phase 2	Polycystic Kidney, Autosomal Dominant Add-on	19	Tolvaptan	zzbqrqagin(enuadpcrhm) = wifofpinsi mhvyhqtyqp (hickjwikyg )	-	01 Feb 2023

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