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

Key Takeaways

• Approved drugs in the ADHF – preserved ejection fraction (acute HFpEF) space target natriuretic peptide receptors. These drugs are administered via the intravenous route.
• Approved drugs in the ADHF – reduced ejection fraction (acute HFrEF) 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.
• The majority of industry-sponsored drugs in active clinical development for acute HFrEF are in Phase II. Therapies in development for acute HFrEF target guanylate cyclase, ryanodine receptor, sarcoplasmic reticulum Ca2+-ATPase, troponin, beta-3 adrenergic receptor, relaxin family peptide receptors 1–4, and natriuretic peptide receptors. These therapies are administered via the intravenous and oral routes.
• High-impact upcoming events for drugs in the acute HFrEF space comprise topline Phase II trial results for istaroxime and topline Phase IIa trial results for APD418.
• The overall likelihood of approval of a Phase I acute HFrEF asset is 1.5%, and the average probability a drug advances from Phase III is 28.6%. Drugs, on average, take 13.6 years from Phase I to approval, compared to 10.2 years in the overall cardiovascular space.
• 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 58% of trials in Phase III–IV, and 42% 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.