nedocromil
Trade name: tilade
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
Earliest trial started Sep 1, 1991 (NCT00000575)
Timeline
1990s
- Jan 1, 1991
Earliest Phase 3 Sponsor(trial)
- Dec 30, 1992
Fisons — Earliest FDA Approval
- Dec 30, 1992
King Pharmaceuticals — NDA Secondary Org
- Dec 30, 1992
Fisons — NDA Organization
- Oct 1, 1997
Sanofi-Aventis — NDA Secondary Org
- Dec 8, 1999
Allergan — NDA Secondary Org
- Dec 8, 1999
SmithKline Beecham — NDA Secondary Org
2010s
- Jan 1, 2010
Earliest Phase 1 Sponsor(trial)
- Aug 22, 2012
Akorn, Inc. — Marketing Organization
- 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
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
- ChEMBLCHEMBL746 ↗
- WikipediaNedocromil ↗
- NCATS0B535E0BN0 ↗
- ChEMBLCHEMBL915 ↗
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 ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05095311 | Phase 4 | May 19, 2021 | Indiana University |
| NCT01061333 | Phase 1 | Jun 1, 2010 | Merck |
| NCT00135681 | N/A | Dec 1, 1996 | National Heart, Lung, and Blood Institute (NHLBI), University of New Mexico |
| NCT00000575 | Phase 3 | Sep 1, 1991 | Asthma, 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 |
Organizations
Research & Development (11)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | Government | 2 | 0 | 2 | 1991 |
| University of New Mexico | Academic/Hospital | 2 | 1 | 2 | 1991 |
| Asthma, Inc. | Academic/Hospital | 1 | 0 | 1 | 1991 |
| Harvard University | Academic/Hospital | 1 | 0 | 1 | 1991 |
| Indiana University | Academic/Hospital | 1 | 1 | 1 | 2021 |
| Johns Hopkins University | Academic/Hospital | 1 | 1 | 1 | 1991 |
| Merck | For profit | 1 | 1 | 1 | 2010 |
| University of California, San Diego | Academic/Hospital | 1 | 0 | 1 | 1991 |
| University of Colorado, Denver | Academic/Hospital | 1 | 0 | 1 | 1991 |
| University of Toronto | Academic/Hospital | 1 | 0 | 1 | 1991 |
| Washington University in St. Louis | Academic/Hospital | 1 | 0 | 1 | 1991 |
Marketing (7)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Akorn, Inc. | For profit | MKTG | Aug 22, 2012 |
| Allergan | For profit | NDA2 | Dec 8, 1999 |
| Epic Pharma Llc | For profit | MKTG | Aug 22, 2012 |
| Fisons | For profit | NDA | Dec 30, 1992 |
| King Pharmaceuticals | For profit | NDA2 | Dec 30, 1992 |
| Sanofi-Aventis | For profit | NDA2 | Oct 1, 1997 |
| SmithKline Beecham | For profit | NDA2 | Dec 8, 1999 |