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DA-8159 (Udenafil)
DA-8159 (Udenafil) is a PDE5 inhibitor Small molecule drug developed by Dong-A Pharmaceutical Co., Ltd.. It is currently in Phase 3 development for Erectile dysfunction.
DA-8159 (Udenafil) inhibits phosphodiesterase type 5 (PDE5), increasing cyclic GMP levels to promote smooth muscle relaxation and improve blood flow.
DA-8159 (Udenafil) inhibits phosphodiesterase type 5 (PDE5), increasing cyclic GMP levels to promote smooth muscle relaxation and improve blood flow. Used for Erectile dysfunction.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | DA-8159 (Udenafil) |
|---|---|
| Sponsor | Dong-A Pharmaceutical Co., Ltd. |
| Drug class | PDE5 inhibitor |
| Target | PDE5 (phosphodiesterase type 5) |
| Modality | Small molecule |
| Therapeutic area | Urology |
| Phase | Phase 3 |
Mechanism of action
Udenafil is a PDE5 inhibitor that works by blocking the enzyme responsible for degrading cyclic guanosine monophosphate (cGMP) in smooth muscle cells. By preventing cGMP breakdown, the drug allows sustained smooth muscle relaxation and vasodilation, particularly in the corpus cavernosum of the penis. This mechanism improves erectile function by enhancing blood flow and penile rigidity.
Approved indications
- Erectile dysfunction
Common side effects
- Headache
- Flushing
- Dyspepsia
- Nasal congestion
- Back pain
- Myalgia
Key clinical trials
- A Extension Study of Udenafil in Adolescents (PHASE3)
- Fontan Udenafil Exercise Longitudinal Assessment Trial - 2 (PHASE3)
- Evaluation of Fontan-associated Hepatic Stiffness and the Efficacy of Udenafil in Reducing Liver Stiffness (PHASE3)
- Fontan Udenafil Exercise Longitudinal Assessment Trial (PHASE3)
- Pharmacokinetic/Pharmacodynamic Study of Udenafil in Adolescents (PHASE1, PHASE2)
- A Study Of The Evaluation Of Patients Opulation With Erectile Dysfunction, Treated With Sildenafil
- The Efficacy and Safety of Udenafil in Patients With Erectile Dysfunction After Bilateral Nerve-sparing Radical Prostatectomy (PHASE4)
- Efficacy and Safety Study of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH) (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- DA-8159 (Udenafil) CI brief — competitive landscape report
- DA-8159 (Udenafil) updates RSS · CI watch RSS
- Dong-A Pharmaceutical Co., Ltd. portfolio CI
Frequently asked questions about DA-8159 (Udenafil)
What is DA-8159 (Udenafil)?
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What is DA-8159 (Udenafil) used for?
Who makes DA-8159 (Udenafil)?
What drug class is DA-8159 (Udenafil) in?
What development phase is DA-8159 (Udenafil) in?
What are the side effects of DA-8159 (Udenafil)?
What does DA-8159 (Udenafil) target?
Related
- Drug class: All PDE5 inhibitor drugs
- Target: All drugs targeting PDE5 (phosphodiesterase type 5)
- Manufacturer: Dong-A Pharmaceutical Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Urology
- Indication: Drugs for Erectile dysfunction
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing