Wednesday, July 8, 2026

Drug profile · INN

mirabegron

mirabegron (BETMIGA) is a beta-3 adrenergic receptor agonist. Associated with Sunshine Guojian Pharmaceutical (Shanghai) Co.,. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved PMDA: approved NMPA: clinical trials Genito-urinary system and sex hormones (G04) G04BD12
US status approved
Patents linked 1
Pipeline programs 7
News articles 0
Drug details — mirabegron
US status
approved
Class
Genito-urinary system and sex hormones (G04)
Route
ORAL
Patents
1
Programs
7
Data quality
0.89

Quick answer

mirabegron (BETMIGA) is a beta-3 adrenergic receptor agonist. Associated with Sunshine Guojian Pharmaceutical (Shanghai) Co.,. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN mirabegron
Brand BETMIGA
Mechanism Beta-3 adrenergic receptor agonist
Target Beta-3 adrenergic receptor
Therapeutic class Genito-urinary system and sex hormones (G04)
Route ORAL
Formulation FOR SUSPENSION, EXTENDED RELEASE
ATC code G04BD12

Mechanism of action

Beta-3 adrenergic receptor agonist

Primary target: Beta-3 adrenergic receptor

Approval history

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

Pipeline programs

  1. Mirabegron Phase 3 · Astellas Pharma · Overactive Bladder (OAB)
  2. Mirabegron Phase 3 · Astellas Pharma · Neurogenic detrusor overactivity (NDO)
  3. CFA-1048-1-25 Phase 1 · Tillomed Laboratories · No medical condition.
  4. CFA-1048-2-25 Phase 1 · Tillomed Laboratories · No medical condition.
  5. CFA-1048-3-25 Phase 1 · Tillomed Laboratories · No medical condition.
  6. mirabegron Approved · Hospital Authority · Sjogren's Syndrome
  7. mirabegron Approved · Chinese Academy of · Sjogren's Syndrome

Related & competitor drugs

  1. apomorphine Genito-urinary system and sex hormones (G04)
  2. oxybutynin Genito-urinary system and sex hormones (G04)
  3. raloxifene Genito-urinary system and sex hormones (G03)
  4. sildenafil Genito-urinary system and sex hormones (G04)
  5. silodosin Genito-urinary system and sex hormones (G04)
  6. tadalafil Genito-urinary system and sex hormones (G04)
  1. US 12097189

    Pharmaceutical composition for modified release

    Expires Mon Sep 19 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is mirabegron?

mirabegron (BETMIGA) is a beta-3 adrenergic receptor agonist. Associated with Sunshine Guojian Pharmaceutical (Shanghai) Co.,. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for mirabegron?

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

What is the US approval status of mirabegron?

mirabegron 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.