Onvita® Simenafil Hydrochloride Tablets

Basic Product Information

Brand Name: Onvita® (昂伟达) 
Generic Name: Simenafil Hydrochloride Tablets
Active Ingredient: Simenafil Hydrochloride
Strengths: 5 mg
Drug Category: Highly selective phosphodiesterase type 5 (PDE5) inhibitor
Approval Background: Class 1 innovative drug, jointly developed by Shanghai Institute of Materia Medica, Chinese Academy of Sciences and Suzhou Vigonvita Life Sciences. Approved by the National Medical Products Administration (NMPA) for marketing in China in July 2025.
Indication: For the treatment of male erectile dysfunction (ED).

Mechanism of Action

Simenafil selectively inhibits phosphodiesterase type 5 (PDE5), relaxes the smooth muscle of the penile corpus cavernosum and increases local blood flow. Erection can only be achieved with sexual stimulation. This product is not an aphrodisiac, and no erection will occur without sexual stimulation.

Product Features

1. Novel chemical structure with high PDE5 selectivity. Onset of action approximately 30 minutes after oral administration; half-life of 8–11 hours for stable sustained therapeutic effect.
2. Low initial therapeutic dose: the recommended starting dose is 2.5 mg.
3. Favourable safety profile. In clinical trials, this product weakly inhibits PDE6 and PDE11; no cases of visual disturbance, back pain or myalgia were observed in trials. Common adverse reactions such as headache, facial flushing and dyspepsia are mild and transient with a lower incidence than other PDE5 inhibitors.
4. Pharmacokinetics are basically unaffected under moderate alcohol intake (heavy alcohol consumption is not recommended).

Dosage and Administration (Summary, please refer to the package insert for full details)

For on-demand use. The recommended starting dose is 2.5 mg. The dose may be adjusted to 5 mg or 10 mg by a doctor according to therapeutic response and tolerability. Take approximately 30 minutes before sexual activity, maximum once per day.

Contraindications

1. Contraindicated in patients allergic to any ingredient of this product.
2. Must not be taken together with nitrate medicines (e.g. nitroglycerin, isosorbide mononitrate). Combined use may cause severe hypotension, which can be life-threatening.
3. Contraindicated for women, children and adolescents under 18 years old.
4. Must not be co-administered with guanylate cyclase stimulators (e.g. riociguat), which may lead to symptomatic hypotension.

Storage and Shelf Life

Store sealed below 30°C. Keep out of reach of children. The shelf life is shown on the outer packaging box.