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mirabegron

Trade name: myrbetriq

Small moleculeapproved

Approved

Jun 28, 2012

Mirabegron (trade name Myrbetriq in the US and Betmiga in Europe) is a drug for the treatment of overactive bladder (OAB). It was developed by Astellas Pharma and was approved in the United States in July 2012. Originally developed as a treatment for diabetes, the development of mirabegron was later refocused to OAB. Mirabegron is an orally bioavailable agonist of the human beta-3 adrenergic receptor (ADRB3), with muscle relaxing, neuroprotective and potential antineoplastic activities. Upon oral administration, mirabegron binds to and activates ADRB3, which leads to smooth muscle relaxation. Mirabegron also restores sympathetic stimulation in mesenchymal stem cell (MSC) niches, inhibits JAK2-mutated hematopoietic stem cell (HSC) expansion and blocks the progression of myeloproliferative neoplasms (MPNs). Lack of sympathetic stimulation of the MSC and HSC niche is associated with the development of MPNs. — NCATS

Clinical trial activity

150 trials · 103 clinical orgs · 13 marketing orgs

Phase 1
44
Phase 2
54
Phase 3
31
Phase 4
40

Earliest trial started Sep 1, 2002 (NCT01478490)

Timeline

2000s

  1. Jan 1, 2002

    Astellas — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2004

    Astellas — Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2008

    Astellas — Earliest Phase 3 Sponsor(trial)

2010s

  1. Jun 28, 2012

    Astellas — Earliest FDA Approval

  2. Jun 28, 2012

    Astellas — NDA Organization

  3. Oct 12, 2018

    Aurobindo Pharma — Marketing Organization

  4. Dec 27, 2019

    Sawai Pharmaceutical — Marketing Organization

2020s

  1. Mar 25, 2021

    Leo Pharma — NDA Secondary Org

  2. Sep 28, 2022

    Lupin — Marketing Organization

  3. Sep 29, 2022

    Zydus Discovery DMCC — Marketing Organization

  4. Jan 9, 2023

    Alkem Labs Ltd — Marketing Organization

  5. Jan 2, 2025

    Apotex — Marketing Organization

  6. Apr 28, 2025

    Ascent Pharmahealth — Marketing Organization

  7. Jun 30, 2025

    Qilu Pharmaceutical Co., Ltd. — Marketing Organization

  8. Nov 4, 2025

    MSN Laboratories — Marketing Organization

  9. Dec 10, 2025

    Sunshine Lake Pharma Co., Ltd. — Marketing Organization

  10. May 1, 2026

    Deva Holding A.S. — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedJun 28, 2012

Chemistry & pharmacology

Loading structure…

SMILES

NC1=NC(CC(=O)NC2=CC=C(CCNC[C@H](O)C3=CC=CC=C3)C=C2)=CS1
Mol. weight
396.506 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

First in class

Sources

Also known as

  • 2-(2-aminothiazol-4-yl)-4'-(2-((2-hydroxy-2-phenylethyl)amino)ethyl)acetanilide
  • betanis
  • betanis
  • betanis
  • betmiga
  • betmiga
  • betmiga
  • betmiga
  • mirabegron
  • mirabegron
  • mirabegron
  • mirabegron
  • mirabegron
  • mirabegron
  • mirabegron
  • mirabegron
  • mirabegron
  • mirabegron
  • mirabegron
  • myrbetriq
  • myrbetriq
  • myrbetriq
  • myrbetriq
  • ym178
  • ym178
  • ym178
  • ym178
  • ym178
  • ym178
  • ym 178
  • ym-178
  • ym-178
  • ym-178

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07187466Phase 4Jan 1, 2026Department of Veteran Affairs
NCT07305298Phase 3Jan 1, 2026Medical University of Lublin, University of Naples Frederico II
NCT07310797Phase 4Jan 1, 2026Tzu Chi University
NCT07261683Phase 2Dec 31, 2025Fudan University
NCT07259148N/ANov 22, 2025Hospital Militar Escuela "Dr. Alejandro Dávila Bolaños"
NCT07017439Phase 3Aug 31, 2025University of Manitoba
NCT07025642N/AJul 1, 2025Mackay Medical College
NCT06791460Phase 2/Phase 3 (Phase 3)Mar 18, 2025Fudan University
NCT06803030Phase 3Feb 1, 2025Government of Nepal, NAMS Bir Hospital
NCT07199894Phase 3Dec 1, 2024Mansoura University
NCT06534762Phase 2Jul 15, 2024Zhejiang University
NCT06551246Phase 3Jun 27, 2024Aarhus University, Gødstrup Hospital
NCT06465576Phase 4May 27, 2024Aarhus University, Gødstrup Hospital
NCT06181591Phase 2Jan 15, 2024Il-Yang Pharm. Co., Ltd., Seoul National University
NCT05713799Phase 2Jan 3, 2024National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NCT06133075Phase 2Nov 22, 2023Cedars-Sinai Medical Center
NCT05880862Early Phase 1 (Phase 1)Sep 28, 2023National Institute on Aging (NIA), University of Texas, Galveston
NCT05992428Phase 1Aug 22, 2023Dong-A Pharmaceutical
NCT05990387Phase 1/Phase 2 (Phase 2)Jul 19, 2023Indiana University, United States Navy
NCT05806164Phase 4Jun 6, 2023Brown University, Howard University, Patient-Centered Outcomes Research Institute, University of Alabama, Birmingham, University of California, San Diego, University of New Mexico
Showing 20 of 150 trials
Page 1 / 8

Organizations

Research & Development (103)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AstellasFor profit665842002
Mansoura UniversityAcademic/Hospital4422018
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government4222013
Tzu Chi UniversityAcademic/Hospital4432015
Department of Veteran AffairsGovernment3232016
Far Eastern Memorial HospitalAcademic/Hospital3322017
Indiana UniversityAcademic/Hospital3222021
Laval UniversityAcademic/Hospital3222013
Mackay Medical CollegeAcademic/Hospital3322021
National Institute on Aging (NIA)Government3022022
Seoul National UniversityAcademic/Hospital3322015
University of KentuckyAcademic/Hospital3332016
Aarhus UniversityAcademic/Hospital2222024
EvergreenHealthAcademic/Hospital2212014
Fudan UniversityAcademic/Hospital2222025
Genuine Research Center, EgyptFor profit2212020
Gødstrup HospitalAcademic/Hospital2022024
United States NavyGovernment2012021
University of Alabama, BirminghamAcademic/Hospital2112021
University of California, San DiegoAcademic/Hospital2122023
103 organizations
Page 1 / 6

Marketing (14)

OrganizationOrg typeRelationshipDate
Alkem Labs LtdFor profitMKTGJan 9, 2023
ApotexFor profitMKTGJan 2, 2025
Ascent PharmahealthFor profitMKTGApr 28, 2025
AstellasFor profitNDAJun 28, 2012
Aurobindo PharmaFor profitMKTGOct 12, 2018
Deva Holding A.S.For profitMKTGMay 1, 2026
Leo PharmaFor profitNDA2Mar 25, 2021
LupinFor profitMKTGSep 28, 2022
LupinFor profitSYNSep 28, 2022
MSN LaboratoriesFor profitMKTGNov 4, 2025
Qilu Pharmaceutical Co., Ltd.For profitMKTGJun 30, 2025
Sawai PharmaceuticalFor profitMKTGDec 27, 2019
Sunshine Lake Pharma Co., Ltd.For profitMKTGDec 10, 2025
Zydus Discovery DMCCFor profitMKTGSep 29, 2022