PDE3 Inhibitor Market: Competitive Landscape, Pipeline, and Market Analysis 2023

PDE3 inhibitors are a class of pharmaceutical agents that target the enzyme phosphodiesterase 3 (PDE3). They work by blocking the PDE3 enzyme, leading to increased levels of cyclic adenosine monophosphate (cAMP) and cyclic guanosine monophosphate (cGMP) in cells. This elevation in cAMP and cGMP levels can have multiple effects, such as relaxation of smooth muscles, vasodilation, inhibition of platelet aggregation, and positive inotropic and chronotropic effects on the heart. Consequently, PDE3 inhibitors find utility in treating conditions like heart failure, angina pectoris, pulmonary arterial hypertension, and certain arrhythmias. According to the World Health Organization (WHO), cardiovascular diseases are the leading cause of death globally, accounting for approximately 17.9 million deaths annually. In Europe, cardiovascular diseases cause more than 4 million deaths per year, with ischemic heart disease being the leading cause of mortality. In the United States, cardiovascular diseases account for nearly 1 in 4 deaths, with heart failure affecting approximately 6.2 million Americans. Pulmonary arterial hypertension is a rare disease, but it still affects around 15-50 individuals per million population in Europe and the United States.

The growth of the PDE3 inhibitor market is driven by several factors. Firstly, the increasing prevalence of cardiovascular diseases, particularly heart failure and angina pectoris, creates a substantial market demand for effective treatment options like PDE3 inhibitors. Additionally, advancements in healthcare infrastructure and the availability of well-established pharmaceutical companies in Europe and the United States further contribute to market growth. Companies such as AOP Orphan Pharma, MediciNova, Orion Corp, Tenax Therap, AbbVie, Bayer, Kyorin, Ligand, Nuance Biotech, SELLAS Life Sciences, SK Bio, STALICLA, Verona Pharma and Sanofi. are pharmaceutical companies operating in the healthcare industry. cater to this category. Moreover, many companies are coming up with new molecules in this space. For instance, Verona Pharma is currently conducting a clinical trial of the drug RPL554 for the treatment of asthma.

Key Developments

• In May 2023, Tenex Therapeutics received a patent allowance for Levosimendan (Oral) in the USA.
• In May 2023, MediciNova received notice of intention to grant a patent for Ibudilast in microorganism infection in Europe.

Approved PDE3 Inhibitor Molecules

• Cilostazol
• Simdax (levosimendan IV)
• Aminophylline
• Eyevinal (ibudilast)

PDE3 Inhibitor Pipeline Molecules

• Levosimendan oral (TNX-103)
• Tipelukast (MN-001)
• Anathromb (anagrelide CR)
• TQC3721

Clinical Activity and Development of PDE3 Inhibitor

In the PDE3 Inhibitor space, there are more than 15 companies, conducting more than more than 100 clinical trials in this category of drugs. For instance,

• In Nov 2020, Otsuka Pharmaceutical completed phase I CiloMecT trial of Cilostazol in Healthy volunteers (Adjunctive therapy) in Germany.
• In June 2023, MediciNova presented efficacy data from a phase IIb trial of Ibudilast in alcoholism at the 46th Annual Research Society on Alcoholism (RSA-2023).