ENTADFI
Peakfinasteride; tadalafil
NDAORALCAPSULE
Approved
Dec 2021
Lifecycle
Peak
Competitive Pressure
30/100
Data completeness
2/8 — Basic
ENTADFI (finasteride; tadalafil) is tadalafil. First approved in 2021.
Drug data last refreshed 16h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ENTADFI is a fixed-dose combination oral capsule containing finasteride (a Type II 5α-reductase inhibitor) and tadalafil (a PDE5 inhibitor) approved in December 2021 for benign prostatic hyperplasia (BPH). Finasteride reduces DHT-dependent prostate enlargement via stable enzyme inhibition, while tadalafil's mechanism in BPH remains partially defined but involves PDE5 inhibition in prostate and bladder smooth muscle. The combination addresses both static prostate volume and dynamic lower urinary tract symptoms in a single daily oral dose.
Peak
Product is in peak commercial maturity post-launch with moderate competitive pressure (30% intensity); brand teams are likely focused on market penetration and differentiation against established monotherapy alternatives.
Mechanism of Action
tadalafil. Finasteride: The development and enlargement of the prostate gland is dependent on the potent androgen, 5α-dihydrotestosterone (DHT). Type II 5α-reductase metabolizes testosterone to DHT in the prostate gland, liver and skin. DHT induces androgenic effects by binding to androgen…
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.