PDE10 Inhibitors Market: Competitive Landscape, Pipeline, and Market Analysis 2024

PDEs are a family of enzymes responsible for the hydrolysis and subsequent inactivation of cyclic nucleotides and have been organized into at least 11 families based on sequence homogeneity, inhibitor sensitivity, and biochemical properties. Phosphodiesterase 10 (PDE10) is an enzyme that plays a role in regulating the levels of cyclic adenosine monophosphate (cAMP) and cyclic guanosine monophosphate (cGMP) in cells. It is primarily found in the brain, specifically in the striatum, which is a region involved in motor control, cognition, and emotion. The mechanism of action of PDE10 Inhibitors is by selectively blocking the activity of the PDE10 enzyme. By inhibiting PDE10, these drugs prevent the breakdown of cyclic adenosine monophosphate (cAMP) and cyclic guanosine monophosphate (cGMP), leading to increased levels of these cyclic nucleotides in cells. PDE10 inhibitors have been verified as an effective therapeutic strategy for CNS disorders, movement disorders, endocrine system diseases, diabetes complications, migraine disorders, opioid-related disorders, and neuromuscular diseases to name a few. Moreover, the increasing prevalence of neurological disorders, diabetic complications, and increasing R&D investments are the key drivers for the PDE10 Inhibitors market. For instance, according to the World Health Organization 2022, Schizophrenia affects approximately 24 million people or 1 in 300 people (0.32%) worldwide. This rate is 1 in 222 people (0.45%) among adults. Moreover, the development of novel molecules by many market players is coming up to overcome challenges in therapy. For instance, Pfizer’s PF-02545920 for the treatment of Schizophrenia is under the various stages of clinical studies.

Key Market Developments:

In April 2020, MediciNova’s developing drug Ibudilast was under study for use in acute respiratory distress syndrome (ARDS) caused by COVID-19.

Drugs under the Pipeline for PDE10 Inhibitors:

• Eyevinal (Ibudilast)
• PF-02545920
• MK-8189
• Lu AF11167
• RO5545965
• OMS824
• Balipodect (TAK-063)
• CPL-500036
• PBF-999
• Gemlapodect (NOE-105)
• EVP6308
• AMG 579

Clinical Activity and Developments of PDE10 Inhibitors:

Till July 2023, more than 10 companies have approximately 12 molecules targetting many CNS diseases. For these molecules, more than 22 clinical trials are being conducted and the majority are in phase-1 and phase-2 clinical trials by the players across the globe. For instance,

• In November 2019, Pfizer completed a phase 2, multicenter, double-blind, randomized, parallel-group, 4-week inpatient study to evaluate the safety and efficacy of two fixed doses of PF-02545920 compared to placebo in the treatment of acute exacerbation of Schizophrenia using Risperidone as an active control.
• In March 2023, MSD completed phase 1, a multiple ascending dose clinical study to evaluate the safety, tolerability, PK, and the effect of MK-8189 on QTc in participants with Schizophrenia.