This Market Spotlight report covers the Acute Decompensated Heart Failure (ADHF) market, comprising key marketed and pipeline drugs, recent events and analyst opinion, clinical trials, probability of success, epidemiology information, licensing and asset acquisition deals, and drug-specific revenues.

Key Takeaways

• Approved drugs in the acute decompensated heart failure (ADHF) space target natriuretic peptide receptors, phosphodiesterase 3, potassium channels, and troponin-C. All of the approved therapies are administered via the intravenous route, with two drugs also being available in an oral formulation.
• Therapies in active clinical development for ADHF are evenly spread across Phase I and Phase II. Therapies in development for ADHF focus on targets such as Na-K-Cl cotransporter, corticotropin releasing factor – receptor2, guanylate cyclase, ryanodine receptor, sarcoplasmic reticulum Ca2+-ATPase, troponin, natriuretic peptide receptors, vasopressin receptors, and phosphodiesterase 9. These therapies are administered via the oral, intravenous, and subcutaneous routes.
• The only high-impact upcoming event in the ADHF space is topline Phase II trial results for BMS-986231. The overall likelihood of approval of a Phase I ADHF asset is 1.8%, and the average probability a drug advances from Phase III is 28.6%. Drugs, on average, take 12.9 years from Phase I to approval, compared to 9.8 years in the overall cardiovascular space.
• There have been only two licensing and asset acquisition deals involving ADHF drugs during 2014–19. The $2,075m acquisition of Cardioxyl by Bristol-Myers Squibb in 2015, which also gave the company full rights to Cardioxyl’s lead asset CXL-1427, a novel nitroxyl (HNO) donor (prodrug) in Phase II clinical development as an intravenous treatment for ADHF, was the largest deal.
• The distribution of clinical trials across Phase I–IV indicates that the majority of trials for ADHF have been in the late phases of development, with 57% of trials in Phase III–IV, and 43% in Phase I–II.
• Clinical trial activity in the ADHF space is dominated by completed trials. Johnson & Johnson has the highest number of completed clinical trials for ADHF, with 17 trials.
• Johnson & Johnson leads industry sponsors with the highest overall number of clinical trials for ADHF, followed by Novartis