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

Phosphodiesterase inhibitors are a class of medications that block the action of phosphodiesterase enzymes, which regulate the levels of cyclic nucleotides, particularly cyclic adenosine monophosphate (cAMP) and cyclic guanosine monophosphate (cGMP). By inhibiting these enzymes, phosphodiesterase inhibitors can modulate intracellular signaling pathways and have diverse therapeutic effects. Phosphodiesterase inhibitors prevent the breakdown of cAMP and cGMP, thereby increasing their intracellular concentrations. Elevated levels of these cyclic nucleotides lead to various downstream effects, including smooth muscle relaxation, vasodilation, bronchodilation, and anti-inflammatory actions. The specific phosphodiesterase isoform targeted by each inhibitor determines its selectivity and therapeutic effects. Phosphodiesterase inhibitors have multiple clinical applications. For instance, phosphodiesterase-5 (PDE-5) inhibitors like sildenafil and tadalafil are commonly used to treat erectile dysfunction by enhancing vasodilation and blood flow to the penile tissues. PDE-3 inhibitors, such as milrinone and inamrinone, are employed in managing heart failure, increasing contractility and vasodilation, improving cardiac output. In addition, phosphodiesterase inhibitors have been investigated for their potential in treating other conditions, including pulmonary hypertension, asthma, chronic obstructive pulmonary disease (COPD), and Raynaud's disease, among others. Extensive research is being conducted globally to discover new and novel molecules to be used, like roflumilast, that is used for the treatment of many indications like COPD. The development and launch of new products will thus increase the market's revenue in the forecasted years.

Several of these inhibitors are in the market, while many are in ongoing clinical trials. Various companies have various products in their pipelines, with 140 products in various stages of clinical trials – 15 in Phase 4, 13 in Phase 3, 9 in Phase 2, and 2 in Phase 1 of the clinical trials.

Key Developments Of Phosphodiesterase Inhibitor

• In March 2020, FDA approved Eucrisa (crisaborole) ointmment 2% in children as young as 3 months of age with mild to-moderate Atopic Dermatitis (AD).
• In Ap 2021, Mezzoin announced re-submission of NDA for it’s Orphan drug Udenafil for the treatment of patients who have undergone Fontan Operation for Simple Ventricle Heart Disease.

Approved Phosphodiesterase Inhibitor molecules

• Simdax (levosimendan IV)
• Daliresp (roflumilast)
• Eucrisa (crisaborole)
• Zydena (udenafil)
• Eyevinal (ibudilast)
• Stendra (avanafil)
• osoresnontrine (BI 409306)
• Ansimar (doxofylline)

Drugs in the Pipeline of Phosphodiesterase Inhibitor

• Eyevinal (Ibudilast)
• Osoresnontrine (BI 409306)
• Zoryve (Roflumilast Cream)
• Ensifentrine (RPL554)
• BI 1015550
• Moizerto (Difamilast)
• Tanimilast (CHF6001)
• Mufemilast (Hemay005)
• Orismilast Oral (LEO 32731)
• PF-02545920
• Agrylin (Anagrelide)
• GSK256066
• MK-8189
• PF-04447943
• Pefcalcitol (M 518101)
• Simmerafil (TPN171H)
• Zatolmilast (BPN14770)
• Perfan (Enoximone)
• Tetomilast (OPC-6535)
• Lu AF11167
• BI-474121
• PF 3882845
• PF-00489791
• Brilacidin (PMX-30063)
• Deuterated S-Lisofylline (PCS499)
• Irsenontrine (E2027)
• Tovinontrine (IMR-687)
• AMG 634
• PF-07038124
• RO5545965
• Inhaled Vardenafil (RT234)
• Lenrispodun (ITI-214)
• Levosimendan Oral (TNX-103)
• Topical Roflumilast Foam (ARQ-154)
• MK 0873
• OMS824
• PF-05180999
• Balipodect (TAK-063)
• Lotamilast 0.5% Ointment (DMVT-501 0.5% Ointment)
• Oglemilast (GRC 3886)
• Tadalafil/Dutasteride (DKF-313)
• Tipelukast (MN-001)
• CPL-500036

Clinical Activity and Developments of Phosphodiesterase Inhibitor

As of July 2023, various companies have approximately 140 products for 669 diseases. For these diseases, many trials are being conducted by players globally. For instance,

• In June 2023, Jinnah Postgraduate Medical Centre completed a Phase 3 clinical trial to assess the efficacy of oral Apremilast in the treatment of Alopecia Areata.
• In January 2023, Beni-Suef University completed a Phase 4 clinical trial to compare and study the effect of Sildenafil Citrate Compared to Estrogen as adjuvant therapy on improvement of endometrial thickness and treatment of unexplained infertility.
• In July 2022. Assiut University completed a Phase 4 clinical trial to assess the efficacy of Sildenafil Citrate to reduce the rate of cesarean section for Intrapartum Fetal Distress during induction of labor.