pecavaptan (BAY1753011) / Bayer - LARVOL DELTA

A multicentre, randomized, double-blind, active and placebo-controlled study of pecavaptan, a dual V1a/V2 vasopressin receptor antagonist, in patients with acute heart failure: The AVANTI trial. (PubMed, Eur J Heart Fail) - P2 | "Adjunctive pecavaptan for 30 days in patients with residual congestion had no impact on weight loss nor on renal function. Post-discharge pecavaptan monotherapy was non-inferior to furosemide monotherapy for weight change over 30 days, but was associated with improved renal function. The increase in congestion events suggests that future trials will need optimized background diuretic dosing."

Clinical • Journal • Cardiovascular • Congestive Heart Failure • Heart Failure

A Study to Learn How the Study Treatment BAY1753011 Moves Into, Through and Out of the Body, How it Works, How Safe it is, and How it Affects the Body When Given Once as Tablet in Male and Female Participants With Reduced Kidney Function Compared to Matched Participants With Normal Kidney Function (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Bayer

New P1 trial • Cardiovascular • Congestive Heart Failure • Heart Failure • Renal Disease

"Discovery of Pecavaptan, a V1a/V2 receptor antagonist, is now being described by Carsten Schmeck @BayerPharma #GPCRs22" (@RSC_BMCS)

A Multicenter, Randomized, Double Blind, Placebo Controlled Study Of Pecavaptan, A Dual V1a/v2 Vasopressin Receptor Antagonist In Patients With Heart Failure: The Avanti Trial (HFSA 2021) - No abstract available

Clinical • Late-breaking abstract • Cardiovascular • Congestive Heart Failure • Heart Failure

AVANTI: A Trial to Study BAY1753011 in Patients With Congestive Heart Failure (clinicaltrials.gov) - P2; N=482; Completed; Sponsor: Bayer; Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Congestive Heart Failure • Heart Failure

AVANTI: A Trial to Study BAY1753011 in Patients With Congestive Heart Failure (clinicaltrials.gov) - P2; N=482; Active, not recruiting; Sponsor: Bayer; Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Congestive Heart Failure • Heart Failure

Vasopressin antagonism in heart failure: a review of the hemodynamic studies and major clinical trials. (PubMed, Ther Adv Cardiovasc Dis) - "A hemodynamic study with the pure V2 antagonist tolvaptan (TV) showed minimal hemodynamic effects. Compared with furosemide in another study, the renal and neurohormonal effects of TV were favorable...A new orally effective balanced V1/V2 antagonist (pecavaptan) is currently undergoing phase II study as both adjunctive and alternative therapy during and after hospitalization for acute HF. The purpose of this review is to summarize what we have learned from the clinical experience with TV and CV, and to suggest implications of these findings for future work with newer agents."

Clinical • Journal • Review • Cardiovascular • Congestive Heart Failure • Heart Failure

Dual Vasopressin Receptor Antagonism to Improve Congestion in Patients With Acute Heart Failure: Design of the AVANTI Trial. (PubMed, J Card Fail) - P2 | "This study will provide the first evidence that a balanced V1a/V2 antagonist may safely enhance decongestion, both as an adjunct to loop diuretics and as an alternative strategy Trial registration number: NCT03901729."

Clinical • Journal • Cardiovascular • Congestive Heart Failure • Heart Failure

AVANTI: A Trial to Study BAY1753011 in Patients With Congestive Heart Failure (clinicaltrials.gov) - P2; N=570; Recruiting; Sponsor: Bayer; N=414 ➔ 570

Clinical • Enrollment change • Cardiovascular • Congestive Heart Failure • Gene Therapies • Heart Failure

Vascular Protection and Decongestion Without Renin-Angiotensin-Aldosterone System Stimulation Mediated by a Novel Dual-Acting Vasopressin V1a/V2 Receptor Antagonist. (PubMed, J Cardiovasc Pharmacol) - "Renal V2 antagonism by BAY 1753011 was compared with the loop diuretic furosemide in acute diuresis experiments in conscious rats. BAY 1753011 dose-dependently decreased the vasopressin-induced expression of the profibrotic/hypertrophic marker plasminogen activator inhibitor-1 and osteopontin in rat cardiomyocytes, while the selective V2 antagonist satavaptan was without any effect. The combined vascular V1a-mediated and renal V2-mediated properties as well as the antihypertrophic/antifibrotic activity enable BAY 1753011 to become a viable treatment option for oral chronic treatment of congestive heart failure."

Journal • Cardiovascular • Congestive Heart Failure • Fibrosis • Gene Therapies • Heart Failure • Immunology

AVANTI: A Trial to Study BAY1753011 in Patients With Congestive Heart Failure (clinicaltrials.gov) - P2; N=414; Recruiting; Sponsor: Bayer; Trial completion date: Jul 2020 ➔ May 2021; Trial primary completion date: Jun 2020 ➔ Apr 2021

Clinical • Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Gene Therapies • Genetic Disorders • Heart Failure

BAY 1753011Dual Vasopressin antagonist (CVCT USA 2019) - No abstract available.

AVANTI: A Trial to Study BAY1753011 in Patients With Congestive Heart Failure (clinicaltrials.gov) - P2; N=414; Recruiting; Sponsor: Bayer; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open