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.
Regional Analysis of PDE5 Inhibitors Market
According to a research study report, the worldwide prevalence of erectile dysfunction is expected to increase to 322 million men by 2025 and is estimated to affect 30 million men in the USA. The crude estimate for pulmonary arterial hypertension is about 5 million adults per year and a prevalence of about 15 per million adults. Angina pectoris is estimated to affect about 1 in 25 Americans, i.e., about 4.3% of the USA adults. The related health issues and the increase in cases due to changing lifestyle will act as the growth driver for the PDE5 inhibitors market.
Latin America
Europe
Asia Pacific
Middle East
North America
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.
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- Bayer
- Mezzion
- IEH Biopharma
- Pfizer
- Respira Therapeutics
- Sanofi
- Sihuan Pharmaceutical
- CMP Pharma