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formoterol

Trade name: foradil

Small moleculeapproved

Approved

Feb 16, 2001

Formoterol, also known as eformoterol, is a long-acting β2 agonist (LABA) used as a bronchodilator in the management of asthma and chronic obstructive pulmonary disease (COPD). Formoterol has an extended duration of action compared to short-acting β2 agonists such as salbutamol (albuterol), which are effective for 4 h to 6 h. Formoterol has a relatively rapid onset of action compared to other LABAs, and is effective within 2-3 minutes. The 2022 Global Initiative for Asthma report recommends a combination formoterol/inhaled corticosteroid inhaler as both a preventer and reliever treatment for asthma in adults. In children, a short-acting β2 adrenergic agonist is still recommended. — Wikipedia

Clinical trial activity

426 trials · 233 clinical orgs · 18 marketing orgs

Phase 1
38
Phase 2
268
Phase 3
185
Phase 4
92

Earliest trial started Jan 1, 2001 (NCT00239278)

Timeline

2000s

  1. Jan 1, 2001

    AstraZeneca — Earliest Phase 2 Sponsor(trial)

  2. Feb 16, 2001

    Novartis — Earliest FDA Approval

  3. Feb 16, 2001

    Novartis — NDA Organization

  4. Jan 1, 2002

    AstraZeneca — Earliest Phase 3 Sponsor(trial)

  5. Jan 1, 2006

    Earliest Phase 1 Sponsor(trial)

  6. Jul 21, 2006

    AstraZeneca — NDA Secondary Org

  7. May 11, 2007

    Mylan — NDA Secondary Org

2010s

  1. Jun 22, 2010

    Merck — Marketing Organization

  2. Jun 22, 2010

    Organon — NDA Secondary Org

  3. Jun 22, 2010

    Merck — NDA Secondary Org

  4. Dec 22, 2015

    Teva — Marketing Organization

  5. Apr 25, 2016

    AstraZeneca — Marketing Organization

  6. Mar 29, 2019

    Circassia Limited — NDA Secondary Org

  7. Mar 29, 2019

    Covis — NDA Secondary Org

  8. Mar 29, 2019

    Advanz Pharma — NDA Secondary Org

2020s

  1. Mar 5, 2021

    Mylan — Marketing Organization

  2. Nov 22, 2021

    Alembic — Marketing Organization

  3. Aug 22, 2022

    Lupin — Marketing Organization

  4. Nov 25, 2022

    Aucta Pharms — Marketing Organization

  5. Nov 25, 2022

    Ritedose — Marketing Organization

  6. Dec 13, 2022

    Wilshire Pharmaceuticals — Marketing Organization

  7. Dec 13, 2022

    Slayback Pharma Llc — Marketing Organization

  8. Mar 22, 2023

    Mankind Pharma — Marketing Organization

  9. Jun 26, 2024

    Micro Labs Ltd India — Marketing Organization

  10. Oct 22, 2024

    LEXENPHARM — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedFeb 16, 2001

Chemistry & pharmacology

Loading structure…

SMILES

COc1ccc(CC(C)NCC(O)c2ccc(O)c(NC=O)c2)cc1.COc1ccc(CC(C)NCC(O)c2ccc(O)c(NC=O)c2)cc1.O.O.O=C(O)/C=C/C(=O)O
Mol. weight
840.92 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

Yes

Sources

Also known as

  • 2'-hydroxy-5'-(1-hydroxy-2-((p-methoxy-alpha-methylphenethyl)amino)ethyl)formanilide
  • 2'-hydroxy-5'-(1-hydroxy-2-((p-methoxy-alpha-methylphenethyl)amino)ethyl)formanilide
  • 2'-hydroxy-5'-{1-hydroxy-2-[(p-methoxy-alpha-methylphenethyl)amino]ethyl}formanilide
  • 2'-hydroxy-5'-{1-hydroxy-2-[(p-methoxy-alpha-methylphenethyl)amino]ethyl}formanilide
  • aclidinium bromide / formoterol fumarate dihydrate
  • aclidinium / formoterol fumarate dihydrate
  • atimos modulite
  • bd-40a
  • bd-40a
  • beclometasone dipropionate anhydrous / formoterol fumarate dihydrate / glycopyrronium
  • beclometasone dipropionate / formoterol fumarate dihydrate / glycopyrronium bromide
  • budesonide / formoterol
  • budesonide / formoterol fumarate dihydrate
  • budesonide-formoterol mixt
  • cgp-25827a
  • cgp-25827a
  • cgp-25827a
  • eformoterol
  • eformoterol
  • eformoterol
  • eformoterol
  • eformoterol
  • eformoterol
  • foradil
  • foradil
  • foradil
  • foradil
  • foradil certihaler
  • foradil certihaler
  • formatris
  • formeterol
  • formoterol
  • formoterol
  • formoterol
  • formoterol
  • formoterol
  • formoterol
  • formoterol
  • formoterol
  • (+)-formoterol
  • formoterol fumarate
  • formoterol fumarate
  • formoterol fumarate
  • formoterol fumarate
  • formoterol fumarate
  • formoterol fumarate dihydrate
  • formoterol fumarate dihydrate
  • formoterol fumarate dihydrate
  • formoterol fumarate hydrate
  • formoterol fumarate hydrate
  • formoterolum
  • formoterolum
  • laba
  • n-[2-hydroxy-5-(1-hydroxy-2-{[2-(4-methoxyphenyl)-1-methylethyl]amino}ethyl)phenyl]formamide
  • n-[2-hydroxy-5-(1-hydroxy-2-{[2-(4-methoxyphenyl)-1-methylethyl]amino}ethyl)phenyl]formamide
  • norflouran
  • oxis 12
  • oxis 6
  • performist
  • performist
  • perforomist
  • perforomist
  • perforomist
  • pt005
  • pt005
  • ym-08316
  • ym-08316

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06234345Phase 3Feb 28, 2026Eurofarma Laboratorios S.A.
NCT07022418Phase 2Jan 31, 2026Dialysis Clinic, Inc., Medical University of South Carolina
NCT07272278N/ADec 1, 2025Zhejiang University
NCT07073950Phase 4Nov 14, 2025AstraZeneca, Parexel
NCT06895460Phase 3Jun 20, 2025Nanjing Medical University
NCT06750289Phase 3Mar 31, 2025AstraZeneca, Clinical Research Trials of Florida, Inc., University of Colorado, Denver
NCT06865040N/AMar 4, 2025University of Picardie Jules Verne
NCT06723756Phase 1Jan 23, 2025AstraZeneca, Parexel
NCT06721247Phase 2/Phase 3 (Phase 3)Jan 2, 2025Zagazig University
NCT06590740N/ADec 30, 2024AstraZeneca, Guangzhou Medical University
NCT06597682N/ANov 30, 2024Fudan University
NCT06676319Phase 2Nov 11, 2024Sanofi
NCT06340581Phase 1Oct 17, 2024AstraZeneca, Parexel
NCT06473779Phase 3Sep 30, 2024AstraZeneca, Fortrea
NCT06572228Phase 4Aug 26, 2024Regeneron, Sanofi
NCT06568445Phase 4Aug 12, 2024Jiao Tong University
NCT06429475Phase 3May 25, 2024Africa Health Research Institute, University of Kwa-Zulu Natal
NCT06297668Phase 1Apr 29, 2024AstraZeneca, Parexel
NCT06283966Phase 3Feb 21, 2024AstraZeneca
NCT06075095Phase 3Jan 15, 2024AstraZeneca
Showing 20 of 426 trials
Page 1 / 22

Organizations

Research & Development (233)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AstraZenecaFor profit11610152001
ChiesiFor profit615342004
Pearl TherapeuticsFor profit282832008
NovartisFor profit231652004
DeyFor profit181842002
MundipharmaFor profit171742007
MerckFor profit151332005
ParexelFor profit12042012
GlaxoSmithKlineFor profit9922002
Guangzhou Medical UniversityAcademic/Hospital9532007
SkyePharma AGFor profit9932004
Boehringer IngelheimFor profit8832001
Orion CorporationFor profit8852009
Harvard UniversityAcademic/Hospital7442008
Medical University of LodzAcademic/Hospital6242003
Southern Medical UniversityAcademic/Hospital6522015
University of CopenhagenAcademic/Hospital6432009
University of ManchesterAcademic/Hospital6022009
MylanFor profit5042012
University of DundeeAcademic/Hospital5412006
233 organizations
Page 1 / 12

Marketing (26)

OrganizationOrg typeRelationshipDate
Advanz PharmaFor profitNDA2Mar 29, 2019
AlembicFor profitMKTGNov 22, 2021
AlembicFor profitSYNNov 22, 2021
AstraZenecaFor profitMKTGApr 25, 2016
AstraZenecaFor profitNDA2Jul 21, 2006
AstraZenecaFor profitSYNJul 23, 2020
Aucta PharmsFor profitMKTGNov 25, 2022
Circassia LimitedFor profitNDA2Mar 29, 2019
CovisFor profitNDA2Mar 29, 2019
LEXENPHARMFor profitMKTGOct 22, 2024
LupinFor profitMKTGAug 22, 2022
Mankind PharmaFor profitMKTGMar 22, 2023
MerckFor profitMKTGJun 22, 2010
MerckFor profitNDA2Jun 22, 2010
Micro Labs Ltd IndiaFor profitMKTGJun 26, 2024
MylanFor profitNDA2May 11, 2007
MylanFor profitMKTGMar 5, 2021
MylanFor profitSYNMar 15, 2022
NovartisFor profitNDAFeb 16, 2001
OrganonFor profitNDA2Jun 22, 2010
OrganonFor profitSYNJun 22, 2010
RitedoseFor profitMKTGNov 25, 2022
Slayback Pharma LlcFor profitMKTGDec 13, 2022
TevaFor profitMKTGDec 22, 2015
TevaFor profitSYNJun 22, 2021
Wilshire PharmaceuticalsFor profitMKTGDec 13, 2022