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Udenafil | CAS No: 268203-93-6 | GMP-certified suppliers
A medication that supports the treatment of erectile dysfunction and is investigated for hypertension management by enhancing vascular function through selective PDE5 inhibition.
Therapeutic categories
Primary indications
- Investigated for use/treatment in erectile dysfunction and hypertension
Product Snapshot
- Udenafil is an oral small molecule formulated as coated and film-coated tablets
- It is primarily indicated for investigation in erectile dysfunction and hypertension
- The compound holds both approved and investigational status in key regulatory markets
Clinical Overview
The pharmacological action of udenafil involves selective inhibition of PDE5, an enzyme responsible for the degradation of cyclic guanosine monophosphate (cGMP) in the corpus cavernosum of the penis. Under normal physiological conditions, sexual stimulation triggers the release of nitric oxide (NO) from nerve terminals and endothelial cells, which activates guanylate cyclase, leading to increased levels of cGMP in smooth muscle cells. Elevated cGMP causes relaxation of penile arterial and trabecular smooth muscle, promoting increased blood flow and facilitating erection. By inhibiting PDE5, udenafil sustains higher concentrations of cGMP, thereby enhancing erectile function.
Beyond erectile dysfunction, udenafil has been investigated for potential applications in the management of hypertension, though its primary clinical use remains in urology. Udenafil is metabolized predominantly by cytochrome P450 enzymes, notably CYP3A4 and CYP3A5 isoforms, which should be considered due to the potential for drug-drug interactions affecting its pharmacokinetics.
Safety and toxicity profiles of udenafil suggest tolerability consistent with other PDE5 inhibitors, though data remain limited outside approved regions. Common adverse effects may include headache, flushing, and nasal congestion, reflecting its vasodilatory mechanism.
For sourcing and quality assurance, procurement of udenafil API should ensure compliance with GMP standards and thorough analytical characterization of purity, polymorphic form, and absence of impurities. Given its status as a controlled pharmaceutical substance in specific jurisdictions, regulatory compliance for import and distribution must be verified.
Identification & chemistry
| Generic name | Udenafil |
|---|---|
| Molecule type | Small molecule |
| CAS | 268203-93-6 |
| UNII | L5IB4XLY36 |
| DrugBank ID | DB06267 |
Pharmacology
| Summary | Udenafil is a selective phosphodiesterase type 5 (PDE5) inhibitor that prevents the degradation of cyclic guanosine monophosphate (cGMP) in penile corpus cavernosum. By enhancing cGMP levels, udenafil promotes smooth muscle relaxation and increased blood flow, facilitating erectile function. The compound is primarily investigated for the treatment of erectile dysfunction and hypertension. |
|---|---|
| Mechanism of action | Udenafil inhibits the cGMP specific phosphodiesterase type 5 (PDE5) which is responsible for degradation of cGMP in the corpus cavernosum located around the penis. Penile erection during sexual stimulation is caused by increased penile blood flow resulting from the relaxation of penile arteries and corpus cavernosal smooth muscle. This response is mediated by the release of nitric oxide (NO) from nerve terminals and endothelial cells, which stimulates the synthesis of cGMP in smooth muscle cells. Cyclic GMP causes smooth muscle relaxation and increased blood flow into the corpus cavernosum. The inhibition of phosphodiesterase type 5 (PDE5) by udenafil enhances erectile function by increasing the amount of cGMP. |
| Pharmacodynamics | Udenafil is a potent selective phosphodiesterase type 5 (PDE5) inhibitor. |
Targets
| Target | Organism | Actions |
|---|---|---|
| cGMP-specific 3',5'-cyclic phosphodiesterase | Humans | inhibitor |
ADME / PK
| Metabolism | Hepatic. Metabolized by CYP3A4 and CYP3A5. |
|---|
Formulation & handling
- Udenafil is a small molecule compound formulated for oral administration, typically in coated or film-coated tablet forms.
- Its moderate lipophilicity (LogP 2.74) and low water solubility suggest consideration for solubilization strategies in formulation.
- Stability handling focuses on maintaining solid-state integrity; no specific peptide or biologic sensitivities apply.
Regulatory status
Udenafil is a type of Phosphodiesterase-5 inhibitors
Phosphodiesterase-5 inhibitors are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that are widely used in the treatment of various medical conditions. These inhibitors target the enzyme phosphodiesterase-5, which plays a crucial role in the regulation of cyclic guanosine monophosphate (cGMP) levels in the body.
By inhibiting phosphodiesterase-5, these APIs effectively increase the concentration of cGMP in certain tissues and organs, leading to several beneficial effects. One of the most well-known applications of phosphodiesterase-5 inhibitors is in the treatment of erectile dysfunction (ED). These medications, such as sildenafil, tadalafil, and vardenafil, work by enhancing the blood flow to the penile tissues, promoting and sustaining erections.
Phosphodiesterase-5 inhibitors also find applications in the treatment of pulmonary arterial hypertension (PAH). By dilating the blood vessels in the lungs, these APIs reduce the workload on the heart and improve exercise capacity in PAH patients. Furthermore, they are being explored for their potential benefits in other areas, such as the treatment of Raynaud's disease and altitude sickness.
It is important to note that phosphodiesterase-5 inhibitors should be used under medical supervision, as they can interact with other medications and have potential side effects. Common side effects include headache, flushing, nasal congestion, and gastrointestinal disturbances.
In summary, phosphodiesterase-5 inhibitors are a class of pharmaceutical APIs that are widely utilized for the treatment of erectile dysfunction and pulmonary arterial hypertension. Their ability to selectively inhibit phosphodiesterase-5 and modulate cGMP levels makes them valuable therapeutic agents in managing these conditions.
Udenafil (Phosphodiesterase-5 inhibitors), classified under Genitourinary Agents
Genitourinary agents are a category of pharmaceutical active ingredients (APIs) that are specifically designed to target and treat disorders related to the genitourinary system. The genitourinary system encompasses the organs and structures involved in the production, storage, and elimination of urine, as well as the reproductive organs.
These APIs play a crucial role in the treatment of various genitourinary conditions, including urinary tract infections (UTIs), erectile dysfunction, urinary incontinence, benign prostatic hyperplasia (BPH), and other related disorders. They exert their therapeutic effects by interacting with specific receptors or enzymes in the genitourinary system, regulating physiological processes, and restoring normal function.
Some commonly used genitourinary agents include alpha-blockers, which relax the smooth muscles in the prostate and bladder neck, improving urine flow in patients with BPH. Additionally, phosphodiesterase type 5 inhibitors (PDE5 inhibitors) are widely prescribed for erectile dysfunction, as they enhance blood flow to the penile tissues, facilitating erection.
These APIs are typically formulated into various dosage forms, such as tablets, capsules, creams, gels, or injections, allowing for convenient administration to patients. The development and production of genitourinary agents involve stringent quality control measures and compliance with regulatory guidelines to ensure safety, efficacy, and consistent product performance.
In summary, genitourinary agents form a crucial category of pharmaceutical APIs used to treat a range of disorders affecting the genitourinary system. Their targeted mechanisms of action and diverse dosage forms make them valuable tools in improving genitourinary health and enhancing patients' quality of life.
Udenafil API manufacturers & distributors
Compare qualified Udenafil API suppliers worldwide. We currently have 1 companies offering Udenafil API, with manufacturing taking place in 1 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Kleem Pharmaceuticals | Producer | India | India | CoA | 22 products |
When sending a request, specify which Udenafil API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
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