Wednesday, July 8, 2026

Drug profile · INN

avanafil

avanafil (SPEDRA) is a phosphodiesterase 5a inhibitor. Associated with A.Menarini Australia Pty Limited. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved Genito-urinary system and sex hormones (G04) G04BE10
US status approved
Patents linked 0
Pipeline programs 0
News articles 0
Drug details — avanafil
US status
approved
Class
Genito-urinary system and sex hormones (G04)
Route
ORAL
Patents
0
Programs
0
Data quality
0.84

Quick answer

avanafil (SPEDRA) is a phosphodiesterase 5a inhibitor. Associated with A.Menarini Australia Pty Limited. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN avanafil
Brand SPEDRA
Mechanism Phosphodiesterase 5A inhibitor
Target cGMP-specific 3',5'-cyclic phosphodiesterase
Therapeutic class Genito-urinary system and sex hormones (G04)
Route ORAL
Formulation TABLET
ATC code G04BE10

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

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

Frequently asked questions

What is avanafil?

avanafil (SPEDRA) is a phosphodiesterase 5a inhibitor. Associated with A.Menarini Australia Pty Limited. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for avanafil?

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

What is the US approval status of avanafil?

avanafil 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.