Wednesday, July 8, 2026

Drug profile · INN

prasterone

prasterone (INTRAROSA) is a unknown. Route of administration: vaginal. Current US regulatory status: approved.

FDA: approved EMA: approved Genito-urinary system and sex hormones (G03) G03XX01
US status approved
Patents linked 0
Pipeline programs 3
News articles 0
Drug details — prasterone
US status
approved
Class
Genito-urinary system and sex hormones (G03)
Route
VAGINAL
Patents
0
Programs
3
Data quality
0.84

Quick answer

prasterone (INTRAROSA) is a unknown. Route of administration: vaginal. Current US regulatory status: approved.

Key facts

INN prasterone
Brand INTRAROSA
Mechanism Unknown
Therapeutic class Genito-urinary system and sex hormones (G03)
Route VAGINAL
Formulation INSERT
ATC code G03XX01

Mechanism of action

Unknown

Approval history

Authority Status Date
FDA approved
EMA approved

Pipeline programs

  1. Intrarosa 6.5 mg pessary Phase 3 · Istituto Gentili Italia · Postmenopausal women with previous breast cancer or current
  2. dehydroepiandrosterone Phase 3 · Ultragenyx UK · Addison's Disease
  3. dehydroepiandrosterone Phase 3 · Ultragenyx UK · Systemic Lupus Erythematosus

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. silodosin Genito-urinary system and sex hormones (G04)

Frequently asked questions

What is prasterone?

prasterone (INTRAROSA) is a unknown. Route of administration: vaginal. Current US regulatory status: approved.

What is the brand name for prasterone?

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

What is the US approval status of prasterone?

prasterone 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.