CDEK
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indacaterol

Trade name: arcapta neohaler

Small moleculeapproved

Approved

Jul 1, 2011

Indacaterol is an ultra-long-acting beta-adrenoceptor agonist developed by Novartis. It was approved by the European Medicines Agency (EMA) under the trade name Onbrez Breezhaler on November 30, 2009, and by the United States Food and Drug Administration (FDA), under the trade name Arcapta Neohaler, on July 1, 2011. It needs to be taken only once a day, unlike the related drugs formoterol and salmeterol. It is licensed only for the treatment of chronic obstructive pulmonary disease (COPD) (long-term data in patients with asthma are thus far lacking). It is delivered as an aerosol formulation through a dry powder inhaler. — NCATS

Clinical trial activity

137 trials · 32 clinical orgs · 2 marketing orgs

Phase 1
9
Phase 2
92
Phase 3
66
Phase 4
30

Earliest trial started Jul 1, 2004 (NCT00098228)

Timeline

2000s

  1. Jan 1, 2004

    Novartis — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2006

    Novartis — Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 2006

    Novartis — Earliest Phase 3 Sponsor(trial)

2010s

  1. Jul 1, 2011

    Novartis — Earliest FDA Approval

  2. Jul 1, 2011

    Novartis — NDA Secondary Org

  3. Jul 1, 2011

    Novartis — NDA Organization

  4. Jul 1, 2011

    Sunovion — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Combination products

  • utibron neohaler

    with glycopyrronium

    Also known as ultibro, ulunar, xoterna

Approval history

  • approvedJul 1, 2011

Chemistry & pharmacology

Loading structure…

SMILES

CCc1cc2c(cc1CC)CC(NC[C@H](O)c1ccc(O)c3[nH]c(=O)ccc13)C2
Mol. weight
392.5 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Discontinued

Oral

No

Parenteral

No

Topical

Yes

Sources

Also known as

  • 5-(2-(5,6-diethylindan-2-ylamino)-1-hydroxyethyl)-8-hydroxy-1h-quinolin-2-one
  • 5-(2-(5,6-diethylindan-2-ylamino)-1-hydroxyethyl)-8-hydroxy-1h-quinolin-2-one
  • 5-(2-(5,6-diethylindan-2-ylamino)-1-hydroxyethyl)-8-hydroxy-1h-quinolin-2-one
  • arcapta neohaler
  • arcapta neohaler
  • arcapta neohaler
  • arcapta neohaler
  • arcapta neohaler
  • glycopyrrolate mixture with indacaterol
  • glycopyrronium bromide / indacaterol maleate
  • indacaterol
  • indacaterol
  • indacaterol
  • indacaterol
  • indacaterol
  • indacaterol
  • indacaterol
  • indacaterol
  • indacaterol / glycopyrronium bromide
  • indacaterol maleate
  • indacaterol maleate
  • indacaterol maleate
  • indacaterol maleate
  • indacaterol maleate
  • indacaterol maleate
  • onbrez
  • onbrez breezhaler
  • onbrez breezhaler
  • qab149
  • qab149
  • qab149
  • qab149
  • qab149
  • qab 149
  • qab 149
  • qab 149
  • qab-149
  • qab-149
  • qab-149
  • qab-149
  • qab149-afa
  • qab149-afa
  • qabi49
  • qabi49
  • qvm149

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06643078Phase 3Dec 11, 2023Haisco Pharmaceutical
NCT06035393Phase 2Oct 27, 2023Hengrui Therapeutics, Inc.
NCT06077019N/AOct 5, 2023University of Copenhagen
NCT06067100N/AOct 5, 2023University of Copenhagen
NCT05562466Phase 3Apr 7, 2023Novartis
NCT05288075Phase 1Feb 28, 2022Orion Corporation
NCT06619210Phase 2Jan 12, 2022Haisco Pharmaceutical, Sichuan University
NCT04856098Phase 1May 7, 2021Orion Corporation
NCT04589663Phase 2Jan 18, 2021Novartis
NCT04259164Phase 3Feb 29, 2020University of Groningen
NCT03379233Phase 3Jul 11, 2018Novartis
NCT03257995Phase 2Sep 5, 2017Novartis
NCT03108027Phase 2Jun 19, 2017Novartis
NCT03100825Phase 3Apr 28, 2017Novartis
NCT03100500Phase 3Apr 25, 2017Novartis
NCT02892019Phase 2Apr 18, 2017Novartis
NCT02953041Phase 4Oct 1, 2016University of Saskatchewan
NCT02867761Phase 3Sep 1, 2016National Heart, Lung, and Blood Institute (NHLBI), University of California, San Francisco, University of Michigan
NCT02813200Phase 4Sep 1, 2016University of Bordeaux
NCT02693769Phase 2/Phase 3 (Phase 3)Jul 1, 2016Mundipharma
Showing 20 of 137 trials
Page 1 / 7

Organizations

Research & Development (32)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
NovartisFor profit11210852004
University of MilanAcademic/Hospital4422011
AstraZenecaFor profit3322012
University of PaviaAcademic/Hospital3012011
Government of MexicoGovernment2212012
Haisco PharmaceuticalFor profit2222022
MerckFor profit2012007
Orion CorporationFor profit2212021
Schering-PloughFor profit2012007
University of CopenhagenAcademic/Hospital2212023
University of GroningenAcademic/Hospital2222015
Cantonal Hospital of St. GallenAcademic/Hospital1012012
Federal University of Health Science of Porto AlegreAcademic/Hospital1112013
GlaxoSmithKlineFor profit1112014
Hengrui Therapeutics, Inc.For profit1112023
Instituto Nacional De Enfermedades Respiratorias Ismael Cosio VillegasAcademic/Hospital1012012
Laval UniversityAcademic/Hospital1112016
MundipharmaFor profit1112016
National Heart, Lung, and Blood Institute (NHLBI)Government1012016
ParexelFor profit1012015
32 organizations
Page 1 / 2

Marketing (3)

OrganizationOrg typeRelationshipDate
NovartisFor profitNDA2Jul 1, 2011
NovartisFor profitNDAJul 1, 2011
SunovionFor profitNDA2Jul 1, 2011