PDE Inhibitors Market: Competitive Landscape, Pipeline, and Market Analysis 2024

A phosphodiesterase (PDE) is an enzyme that breaks a phosphodiester bond. Usually, phosphodiesterase refers to cyclic nucleotide phosphodiesterases, which have great clinical significance. The cyclic nucleotide phosphodiesterases comprise a group of enzymes that degrade the phosphodiester bond in the second messenger molecules cAMP and cGMP. PDE inhibitors, also known as phosphodiesterase inhibitors, target and inhibit specific phosphodiesterase enzymes in the body. Phosphodiesterases are a group of enzymes that catalyze the breakdown of cyclic nucleotides, such as cyclic adenosine monophosphate (cAMP) and cyclic guanosine monophosphate (cGMP). By inhibiting these enzymes, PDE inhibitors increase the levels of cAMP and cGMP, leading to various physiological effects.

PDE inhibitors have been identified as an effective therapeutic strategy for asthma, acute coronary syndrome, CNS disorders, cognition disorders, diabetes complications, endocrine system diseases, inflammation, kidney diseases, metabolic diseases, and urologic diseases, to name a few. Increased prevalence of CNS disorders, asthma, and metabolic disorders are the key drivers for the PDE Inhibitors market. For instance, according to the World Health Organization 2023, Asthma affected an estimated 262 million people in 2019. Moreover, to overcome difficulties in therapy, various market players are developing innovative compounds. For instance, Kowa’s K 134, which indicates obliterans of arteriosclerosis, is under various stages of clinical studies.

Key Market Developments:

• In January 2023, Chiesi completed phase 1, an open-label, non-randomised, parallel-group study to investigate the pharmacokinetics, safety and tolerability following single administration of CHF6001 in subjects with mild, moderate and severe renal impairment in comparison with matched healthy control subjects.

Drugs under the Pipeline for PDE Inhibitors:

•     Tanimilast (CHF6001)
•     PF-04447943
•     Deuterated S-Lisofylline (PCS499)
•     Oglemilast (GRC 3886)
•     AR1001
•     K-134
•     Ibudilast/Bumetanide (STP1)

Clinical Activity and Developments of PDE Inhibitors:

Till July 2023, more than 5 companies have approximately 7 molecules targetting a number of respiratory diseases. For these molecules, more than 80 clinical trials are being conducted and the majority are in phase-1, phase-2 clinical trials by players across the globe. For instance,

• In March 2020, Processa Pharmaceuticals completed phase 2, an open-label study to evaluate the safety and tolerability of PCS499 for the treatment of necrobiosis lipoidica.
• In May 2022, AriBio completed phase 2, a double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of the 26-week treatment of AR1001 in patients with mild to moderate Alzheimer's disease.