nedocromil

Trade name: tilade

Small moleculeapproved

Approved

Dec 30, 1992

Nedocromil is a medication considered as mast cell stabilizer used to treat itching associated with allergic conjunctivitis. Nedocromil has been shown to inhibit the in vitro activation of, and mediator release from, a variety of inflammatory cell types associated with asthma, including eosinophils, neutrophils, macrophages, mast cells, monocytes, and platelets. Nedocromil inhibits activation and release of inflammatory mediators such as histamine, prostaglandin D2 and leukotrienes c4 from different types of cells in the lumen and mucosa of the bronchial tree. These mediators are derived from arachidonic acid metabolism through the lipoxygenase and cyclo-oxygenase pathways. The mechanism of action of nedocromil may be due partly to inhibition of axon reflexes and release of sensory neuropeptides, such as substance P, neurokinin A, and calcitonin-geneñrelated peptides. The result is inhibition of bradykinin-induced bronchoconstriction. Nedocromil does not possess any bronchodilator, antihistamine, or corticosteroid activity. Nedocromil is indicated for the treatment of itching associated with allergic conjunctivitis. — NCATS

Clinical trial activity

4 trials · 11 clinical orgs · 7 marketing orgs

Phase 1
1
Phase 2
1
Phase 3
1
Phase 4
1

Earliest trial started Sep 1, 1991 (NCT00000575)

Timeline

1990s

  1. Jan 1, 1991

    Earliest Phase 3 Sponsor(trial)

  2. Dec 30, 1992

    Fisons — Earliest FDA Approval

  3. Dec 30, 1992

    King Pharmaceuticals — NDA Secondary Org

  4. Dec 30, 1992

    Fisons — NDA Organization

  5. Oct 1, 1997

    Sanofi-Aventis — NDA Secondary Org

  6. Dec 8, 1999

    Allergan — NDA Secondary Org

  7. Dec 8, 1999

    SmithKline Beecham — NDA Secondary Org

2010s

  1. Jan 1, 2010

    Earliest Phase 1 Sponsor(trial)

  2. Aug 22, 2012

    Akorn, Inc. — Marketing Organization

  3. Aug 22, 2012

    Epic Pharma Llc — Marketing Organization

Indications

Mechanism of action

  • Unspecified targetOTHER

    Unknown

    Mode of action not fully understood; it seems to inhibit calcium influx into mast cells, stabilizing them

Approval history

  • approvedDec 30, 1992

Chemistry & pharmacology

Loading structure…

SMILES

CCCc1c2oc(C(=O)O)cc(=O)c2cc2c(=O)cc(C(=O)O)n(CC)c12
Mol. weight
371.35 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Discontinued

Oral

No

Parenteral

No

Topical

Yes

Sources

Also known as

  • 9-ethyl-6,9-dihydro-4,6-dioxo-10-propyl-4h-pyrano(3,2-g)chinolin-2,8-dicarbonsaeure
  • 9-ethyl-6,9-dihydro-4,6-dioxo-10-propyl-4h-pyrano(3,2-g)chinolin-2,8-dicarbonsaeure
  • 9-ethyl-6,9-dihydro-4,6-dioxo-10-propyl-4h-pyrano(3,2-g)quinoline-2,8-dicarboxylic acid
  • 9-ethyl-6,9-dihydro-4,6-dioxo-10-propyl-4h-pyrano(3,2-g)quinoline-2,8-dicarboxylic acid
  • alocril
  • alocril
  • fpl-59002
  • fpl-59002
  • fpl-59002kp
  • fpl-59002kp
  • nedocromil
  • nedocromil
  • nedocromil
  • nedocromil
  • nedocromil
  • nedocromil
  • nedocromil
  • nedocromil
  • nedocromil
  • nedocromil
  • nedocromilo
  • nedocromilo
  • nedocromil sodium
  • nedocromil sodium
  • nedocromil sodium
  • nedocromil sodium
  • nedocromilum
  • nedocromilum
  • rapitil
  • rapitil
  • tilade
  • tilade
  • tilade
  • tilarin
  • tilarin

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05095311Phase 4May 19, 2021Indiana University
NCT01061333Phase 1Jun 1, 2010Merck
NCT00135681N/ADec 1, 1996National Heart, Lung, and Blood Institute (NHLBI), University of New Mexico
NCT00000575Phase 3Sep 1, 1991Asthma, Inc., Harvard University, Johns Hopkins University, National Heart, Lung, and Blood Institute (NHLBI), University of California, San Diego, University of Colorado, Denver, University of New Mexico, University of Toronto, Washington University in St. Louis
Showing 4 of 4 trials
Page 1 / 1

Organizations

Research & Development (11)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Heart, Lung, and Blood Institute (NHLBI)Government2021991
University of New MexicoAcademic/Hospital2121991
Asthma, Inc.Academic/Hospital1011991
Harvard UniversityAcademic/Hospital1011991
Indiana UniversityAcademic/Hospital1112021
Johns Hopkins UniversityAcademic/Hospital1111991
MerckFor profit1112010
University of California, San DiegoAcademic/Hospital1011991
University of Colorado, DenverAcademic/Hospital1011991
University of TorontoAcademic/Hospital1011991
Washington University in St. LouisAcademic/Hospital1011991
11 organizations
Page 1 / 1

Marketing (7)

OrganizationOrg typeRelationshipDate
Akorn, Inc.For profitMKTGAug 22, 2012
AllerganFor profitNDA2Dec 8, 1999
Epic Pharma LlcFor profitMKTGAug 22, 2012
FisonsFor profitNDADec 30, 1992
King PharmaceuticalsFor profitNDA2Dec 30, 1992
Sanofi-AventisFor profitNDA2Oct 1, 1997
SmithKline BeechamFor profitNDA2Dec 8, 1999