Wednesday, July 8, 2026

Drug profile · INN

tadalafil

tadalafil (ADCIRCA) is a phosphodiesterase 5a inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved NMPA: clinical trials Genito-urinary system and sex hormones (G04) G04BE08
US status approved
Patents linked 1
Pipeline programs 11
News articles 0
Drug details — tadalafil
US status
approved
Class
Genito-urinary system and sex hormones (G04)
Route
ORAL
Patents
1
Programs
11
Data quality
0.89

Quick answer

tadalafil (ADCIRCA) is a phosphodiesterase 5a inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN tadalafil
Brand ADCIRCA
Mechanism Phosphodiesterase 5A inhibitor
Target cGMP-specific 3',5'-cyclic phosphodiesterase
Therapeutic class Genito-urinary system and sex hormones (G04)
Route ORAL
Formulation SUSPENSION
ATC code G04BE08

Mechanism of action

Phosphodiesterase 5A inhibitor

Primary target: cGMP-specific 3',5'-cyclic phosphodiesterase

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
NMPA clinical trials

Pipeline programs

  1. 5 mg Tadalafil Phase 3 · Eli Lilly and · Benign Prostate Hyperplasia
  2. APHP230847 Phase 3 · PARItec · Pulmonary arterial hypertension
  3. Intervention - a validated home BP monitor and support from the specialist nurse Phase 3 · United Therapeutics Europe · Stroke
  4. Tadalafil Phase 3 · Eli Lilly and · Hypertension, Pulmonary
  5. Tadalafil Phase 3 · United Therapeutics Europe · Pulmonary Hypertension
  6. CIALIS 5 mg film-coated tablets Phase 2 · George Institute for · sexual/ erectile function in women and men after treatment f
  7. A randomized for healthy male subjects Phase 1 · Anaxis Pharma · healthy male subjects
  8. IIBSP-OXI-2022-124 Approved · George Institute for · Borderline Personality Disorder.

Related & competitor drugs

  1. apomorphine Genito-urinary system and sex hormones (G04)
  2. mirabegron Genito-urinary system and sex hormones (G04)
  3. oxybutynin Genito-urinary system and sex hormones (G04)
  4. raloxifene Genito-urinary system and sex hormones (G03)
  5. sildenafil Genito-urinary system and sex hormones (G04)
  6. sildenafil citrate Phosphodiesterase 5A inhibitor
  1. US 7417044

    Tadalafil having a large particle size and a process for preparation thereof

    Expires Mon Aug 21 2028 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is tadalafil?

tadalafil (ADCIRCA) is a phosphodiesterase 5a inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for tadalafil?

ADCIRCA is a marketed brand name for tadalafil. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of tadalafil?

tadalafil has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.