PDE5 Inhibitors Market: Competitive Landscape, Pipeline, and Market Analysis 2023

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Cyclic guanosine monophosphate-specific phosphodiesterase type 5 (PDE5) is an enzyme from the phosphodiesterase class and prominently found in the corpus cavernosum and the retina; it also plays a vital role in the cardiovascular system and lower concentrations in other tissues, including platelets, vascular and visceral smooth muscle, and skeletal muscle. PDE5 inhibitors are vasodilating drugs that inhibit the degradative action of cGMP-specific phosphodiesterase type 5 (PDE5) on cyclic GMP in the smooth muscle cells lining the blood vessels supplying various tissues. PDE5 inhibitors are indicated for erectile dysfunction, idiopathic pulmonary hypertension, premature ejaculation, antianginal, and others. Bayer, Mezzion, IEH Biopharma, Pfizer, Respira Therapeutics, Sanofi, Sihuan Pharmaceutical, and CMP Pharma are major players in the PDE5 inhibitors market.

Approved Drug Molecules and Brand Names for PDE5 Inhibitors:

  • Sildenafil
  • Tadalafil
  • Vardenafil
  • Zydena (Udenafil)
  • Stendra (Avanafil)

Drugs under the Pipeline for phosphodiesterase type 5 (PDE5) Inhibitors:

  • Simmerafil (TPN171H)
  • PF 3882845
  • PF-00489791
  • Inhaled Vardenafil (RT234)
  • Tadalafil/Dutasteride (DKF-313)
  • KD027
  • Fadanafil (XZP-5849)
  • Leucine/Metformin/Sildenafil (NS-0200)
  • Liqrev (Sildenafil oral suspension)

Key Market Developments:

  • In Apr 2022, Respira Therapeutics’s Vardenafil received an Orphan Drug status for pulmonary arterial hypertension in the USA.
  • In Apr 2023, Mezzion Pharma planned to launch Udenafil for congenital heart defects in the USA.

Clinical Activity and Developments of PDE5 Inhibitors:

Currently, there are 13 drug products in the PDE5 Inhibitors, including five approved drug products and the rest of them are in the clinical development phases.

  • In Feb 2023, Vigonvita Life Sciences completed a phase-III clinical trials in erectile dysfunction in China.
  • In Jun 2022, Pfizer completed the investigator sponsored phase-III SilHF trial in heart failure in the UK, Israel, Italy and Norway.

 

Molecule Name

Number of Studies

Simmerafil (TPN171H)

11

PF 3882845

6

PF-00489791

6

Inhaled Vardenafil (RT234)

5

Tadalafil/Dutasteride (DKF-313)

4

KD027

3

Fadanafil (XZP-5849)

2

Leucine/Metformin/Sildenafil (NS-0200)

2

Liqrev (Sildenafil oral suspension)

1

Target Indication Analysis of PDE5 Inhibitors Market

PDE5 inhibitors such as Sildenafil, Tadalafil, Vardenafil, Udenafil, and Avanafil are indicated for treatment of erectile dysfunction, idiopathic pulmonary hypertension, premature ejaculation, high altitude illness, antianginal, and lower urinary tract symptoms. Other evidence-based indications include heart failure, stroke, peripheral neuropathy, improving fertility, peripheral arterial disease, and diabetic neuropathy.

Key Features of the Reports

  • The report provides granular level information about the market size, regional market share, historic market (2019-2023), and forecast (2024-2030)
  • The report covers in-detail insights about the competitor’s overview, company share analysis, key market developments, and their key strategies
  • The report outlines drivers, restraints, unmet needs, and trends that are currently affecting the market
  • The report tracks recent innovations, key developments, and start-up details that are actively working in the market
  • The report provides a plethora of information about market entry strategies, regulatory framework, and reimbursement scenario

Frequently Asked Questions

Sildenafil, Tadalafil, Vardenafil, Zydena (Udenafil), and Stendra (Avanafil) are the approved PDE5 inhibitors.

Bayer, Mezzion, IEH Biopharma, Pfizer, Respira Therapeutics, Sanofi, Sihuan Pharmaceutical, and CMP Pharma are some of the major players in the PDE5 inhibitors market.

Major indications for PDE5 inhibitors are erectile dysfunction, idiopathic pulmonary hypertension, premature ejaculation, high altitude illness, antianginal, and lower urinary tract symptoms.

There are a total of nine molecules in the clinical development phases for PDE5 inhibitors.

  • Bayer
  • Mezzion
  • IEH Biopharma
  • Pfizer
  • Respira Therapeutics
  • Sanofi
  • Sihuan Pharmaceutical
  • CMP Pharma

 

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