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cromoglicic acid

Trade name: Intal

Small moleculeapproved

Approved

May 28, 1982

Cromolyn is a mast cell stabilizer. In vitro and in vivo animal studies have shown that cromolyn sodium inhibits the degranulation of sensitized mast cells, which occurs after exposure to specific antigens. Cromolyn sodium acts by inhibiting the release of histamine and SRS-A (slow-reacting substance of anaphylaxis) from the mast cell. Cromolyn is indicated in the management of patients with mastocytosis, prophylaxis (long-term control) of bronchial asthma, prevention of exercise-induced bronchospasm, prevention and treatment of seasonal and perennial allergic rhinitis The most frequently reported adverse reactions attributed to cromolyn sodium treatment were: throat irritation or dryness, bad taste, cough, wheeze, nausea. — NCATS

Clinical trial activity

28 trials · 35 clinical orgs · 32 marketing orgs

Phase 1
8
Phase 2
21
Phase 3
5
Phase 4
2

Earliest trial started Feb 1, 1990 (NCT02177370)

Timeline

1980s

  1. May 28, 1982

    Earliest FDA Approval

  2. May 28, 1982

    King Pharmaceuticals — NDA Secondary Org

  3. Oct 3, 1984

    Allergan — NDA Secondary Org

  4. Oct 3, 1984

    SmithKline Beckman — NDA Secondary Org

1990s

  1. Jan 1, 1990

    Boehringer Ingelheim — Earliest Phase 3 Sponsor(trial)

  2. Apr 26, 1994

    Mylan — NDA Secondary Org

  3. Apr 26, 1994

    Eugia Pharma — Marketing Organization

  4. Jan 30, 1995

    Bausch & Lomb — Marketing Organization

  5. Jan 3, 1997

    Blacksmith Brands — NDA Secondary Org

  6. Apr 29, 1998

    Akorn, Inc. — Marketing Organization

  7. Apr 29, 1998

    Sciegen Pharmaceticals — Marketing Organization

  8. Apr 29, 1998

    Saptalis Pharmaceuticals — Marketing Organization

  9. Apr 27, 1999

    King Pharmaceuticals — Marketing Organization

  10. Jun 16, 1999

    Sandoz — Marketing Organization

  11. Jun 16, 1999

    Novartis — Marketing Organization

  12. Jul 19, 1999

    Actavis — Marketing Organization

  13. Sep 30, 1999

    Roxane Laboratories — Marketing Organization

  14. Sep 30, 1999

    Boehringer Ingelheim — Marketing Organization

  15. Oct 25, 1999

    Wockhardt — Marketing Organization

2000s

  1. Jan 18, 2000

    Teva — Marketing Organization

  2. Apr 21, 2000

    Fera Development, LLC — Marketing Organization

  3. Apr 21, 2000

    Virtus Pharms — Marketing Organization

  4. Dec 21, 2000

    Bausch Health Companies — Marketing Organization

  5. Jan 26, 2001

    Apotex — Marketing Organization

  6. Dec 12, 2001

    Perrigo — Marketing Organization

  7. Apr 30, 2002

    Hikma — Marketing Organization

  8. Jun 17, 2005

    Watson Pharmaceuticals — Marketing Organization

  9. Jan 1, 2007

    Earliest Phase 2 Sponsor(trial)

  10. Sep 7, 2007

    Hh And P — Marketing Organization

  11. Dec 18, 2009

    General Pharms — Marketing Organization

2010s

  1. Oct 27, 2011

    Rising Pharmaceuticals — Marketing Organization

  2. Jan 1, 2013

    Earliest Phase 1 Sponsor(trial)

  3. Apr 4, 2013

    Micro Labs Ltd India — Marketing Organization

  4. Oct 16, 2017

    Ailex Pharmaceuticals — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

  • Unspecified targetOTHER

    Unknown

Approval history

  • approvedPriority reviewMay 28, 1982

Chemistry & pharmacology

Loading structure…

SMILES

O=C(O)c1cc(=O)c2c(OCC(O)COc3cccc4oc(C(=O)O)cc(=O)c34)cccc2o1
Mol. weight
468.37 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral, Topical
Availability
Over the Counter

Oral

Yes

Parenteral

No

Topical

Yes

Sources

Also known as

  • 5-[3-(2-carboxy-4-oxo-4h-5-chromenyloxy)-2-hydroxypropoxy]-4-oxo-4h-2-chromenecarboxylic acid
  • 5-[3-(2-carboxy-4-oxo-4h-5-chromenyloxy)-2-hydroxypropoxy]-4-oxo-4h-2-chromenecarboxylic acid
  • acide cromoglicique
  • acide cromoglicique
  • acido cromoglicico
  • acido cromoglicico
  • acidum cromoglicicum
  • acidum cromoglicicum
  • aerocrom
  • allercrom
  • aspire
  • brol-eze
  • catacrom
  • clariteyes
  • crolom
  • crolom
  • cromogen
  • cromogen e-breathe
  • cromoglicate
  • cromoglicate
  • cromoglicate
  • cromoglicate
  • cromoglicic acid
  • cromoglicic acid
  • cromoglicic acid
  • cromoglicic acid
  • cromoglicic acid
  • cromoglicic acid
  • cromoglycate
  • cromoglycate
  • cromoglycate
  • cromoglycic acid
  • cromoglycic acid
  • cromoglycic acid
  • cromoglycic acid
  • cromolux
  • cromolyn
  • cromolyn
  • cromolyn
  • cromolyn
  • cromolyn
  • cromolyn
  • cromolyn disodium
  • cromolyn disodium salt
  • cromolyn sodium
  • cromolyn sodium
  • cromolyn sodium
  • cromolyn sodium
  • cromolyn sodium
  • cromoptic
  • cromoptic
  • cromosol
  • cromosol optha
  • cusilyn
  • disodium cromoglycate
  • disodium cromoglycate
  • disodium cromoglycate
  • dominion pharma hayfever
  • eye-crom
  • fpl-670
  • fpl-670
  • gastrocrom
  • gastrocrom
  • glycavent
  • gppe syncroner inha
  • gynazole
  • hay-crom
  • intal
  • intal
  • intal
  • intal
  • intal
  • intal 5
  • lomudal
  • lomudal
  • lomusol
  • lomusol
  • murine
  • murine
  • nalcrom
  • nalcrom
  • nalcrom
  • nasalcrom
  • nasalcrom
  • opticrom
  • opticrom
  • opticrom aq
  • pa101b
  • resiston one
  • resiston treatment pack
  • rvt-1601
  • rynacrom
  • rynacrom
  • rynacrom allergy
  • rynacrom co
  • sodium cromoglicate
  • sodium cromoglicate
  • sodium cromoglicate
  • sodium cromoglicate
  • sodium cromoglicate
  • sodium cromoglicate
  • sodium cromoglycate
  • sodium cromolyn
  • steri-neb cromogen
  • vivicrom
  • vividrin
  • vividrin
  • viz-on

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07142291Phase 2Nov 30, 2025PhenoNet, Inc.
NCT05077917Phase 3Nov 30, 2021Texas Tech University
NCT05076682Phase 2Oct 15, 2021Fudan University
NCT04846348Phase 2Jul 26, 2021Mayo Clinic
NCT04570644Phase 1/Phase 2 (Phase 2)Aug 28, 2020AZTherapies, Inc.
NCT04408664Phase 3Jun 30, 2020Algemeen Ziekenhuis Maria Middelares, Hasselt University, Katholieke Universiteit Leuven
NCT04428775Phase 2Jun 15, 2020AZTherapies, Inc.
NCT04007120Phase 1Aug 31, 2019Respivant Sciences Inc.
NCT03794076Phase 1/Phase 2 (Phase 2)Apr 1, 2019Stanley Medical Research Institute, University of Pittsburgh
NCT03864328Phase 2Mar 29, 2019Respivant Sciences Inc.
NCT03167216Early Phase 1 (Phase 1)Jun 1, 2017National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Northwestern University
NCT03202147Phase 2Jul 1, 2016APCER Life Sciences, AZTherapies, Inc., MedAvante, Pharma Consulting Group AB
NCT02696499Phase 2Feb 1, 2016Patara Pharma
NCT02547818Phase 3Sep 1, 2015APCER Life Sciences, AZTherapies, Inc., KCAS Bio, Pharma Consulting Group AB
NCT02566252Phase 1Jul 1, 2015Pulmotect, Inc., WCCT Global
NCT02478957Phase 2Jun 1, 2015Humboldt University, Patara Pharma
NCT02482324Phase 1Jun 1, 2015AZTherapies, Inc., KCAS Bio, Panax Clinical Research, Pharma Consulting Group AB
NCT02412020Phase 2Feb 1, 2015Patara Pharma
NCT02371941Phase 4Dec 1, 2014University of Tennessee
NCT01841307Phase 1Jun 1, 2014Aradigm Corporation, National Heart, Lung, and Blood Institute (NHLBI), University of California, San Francisco
Showing 20 of 28 trials
Page 1 / 2

Organizations

Research & Development (35)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AZTherapies, Inc.For profit5532015
Patara PharmaFor profit3312015
Pharma Consulting Group ABFor profit3032015
APCER Life SciencesAcademic/Hospital2022015
Katholieke Universiteit LeuvenAcademic/Hospital2222013
KCAS BioFor profit2022015
Leo PharmaFor profit2212012
Respivant Sciences Inc.For profit2222019
Algemeen Ziekenhuis Maria MiddelaresAcademic/Hospital1012020
Aradigm CorporationFor profit1012014
Boehringer IngelheimFor profit1111990
ClinResearch, GmbHFor profit1012007
Fudan UniversityAcademic/Hospital1112021
Hasselt UniversityAcademic/Hospital1012020
Humboldt UniversityAcademic/Hospital1012015
Johannes Gutenburg UniversityAcademic/Hospital1012007
Mayo ClinicAcademic/Hospital1112021
MedaFor profit1112007
MedAvanteFor profit1012016
National Heart, Lung, and Blood Institute (NHLBI)Government1012014
35 organizations
Page 1 / 2

Marketing (36)

OrganizationOrg typeRelationshipDate
ActavisFor profitMKTGJul 19, 1999
Ailex PharmaceuticalsFor profitMKTGOct 16, 2017
Akorn, Inc.For profitMKTGApr 29, 1998
AllerganFor profitNDA2Oct 3, 1984
ApotexFor profitMKTGJan 26, 2001
Bausch & LombFor profitMKTGJan 30, 1995
Bausch Health CompaniesFor profitMKTGDec 21, 2000
Blacksmith BrandsFor profitNDA2Jan 3, 1997
Boehringer IngelheimFor profitMKTGSep 30, 1999
Eugia PharmaFor profitMKTGApr 26, 1994
Fera Development, LLCFor profitMKTGApr 21, 2000
FisonsFor profitNDA—
General PharmsFor profitMKTGDec 18, 2009
Hh And PFor profitMKTGSep 7, 2007
HikmaFor profitMKTGApr 30, 2002
King PharmaceuticalsFor profitNDA2May 28, 1982
King PharmaceuticalsFor profitMKTGApr 27, 1999
Micro Labs Ltd IndiaFor profitSYNApr 29, 2022
Micro Labs Ltd IndiaFor profitMKTGApr 4, 2013
MylanFor profitNDA2Apr 26, 1994
NovartisFor profitMKTGJun 16, 1999
PerrigoFor profitMKTGDec 12, 2001
Rising PharmaceuticalsFor profitMKTGOct 27, 2011
Rising PharmaceuticalsFor profitSYNOct 27, 2011
Roxane LaboratoriesFor profitMKTGSep 30, 1999
SandozFor profitMKTGJun 16, 1999
SandozFor profitSYNJun 16, 1999
Sanofi-AventisFor profitNDA2—
Saptalis PharmaceuticalsFor profitMKTGApr 29, 1998
Sciegen PharmaceticalsFor profitMKTGApr 29, 1998
SmithKline BeckmanFor profitNDA2Oct 3, 1984
TevaFor profitMKTGJan 18, 2000
UCBFor profitNDA2—
Virtus PharmsFor profitMKTGApr 21, 2000
Watson PharmaceuticalsFor profitMKTGJun 17, 2005
WockhardtFor profitMKTGOct 25, 1999