flunisolide
Trade name: nasalide
Approved
Sep 24, 1981
Flunisolide is a synthetic corticosteroid. It is administered either as an oral metered-dose inhaler for the treatment of asthma or as a nasal spray for treating allergic rhinitis. Corticosteroids are naturally occurring hormones that prevent or suppress inflammation and immune responses. When given as an intranasal spray, flunisolide reduces watery nasal discharge (rhinorrhea), nasal congestion, postnasal drip, sneezing, and itching oat the back of the throat that are common allergic symptoms. Flunisolide is a glucocorticoid receptor agonist. The antiinflammatory actions of corticosteroids are thought to involve lipocortins, phospholipase A2 inhibitory proteins which, through inhibition arachidonic acid, control the biosynthesis of prostaglandins and leukotrienes. The immune system is suppressed by corticosteroids due to a decrease in the function of the lymphatic system, a reduction in immunoglobulin and complement concentrations, the precipitation of lymphocytopenia, and interference with antigen-antibody binding. Flunisolide binds to plasma transcortin, and it becomes active when it is not bound to transcortin. It is used for the maintenance treatment of asthma as a prophylactic therapy. Flunisolide is marketed as AeroBid, Nasalide, Nasarel. — NCATS
Clinical trial activity
3 trials · 4 clinical orgs · 11 marketing orgs
Earliest trial started Sep 13, 2005 (NCT00203684)
Timeline
1980s
1990s
- Mar 8, 1995
Teva — NDA Secondary Org
2000s
- Feb 20, 2002
Bausch Health Companies — Marketing Organization
- Feb 20, 2002
Bausch & Lomb — Marketing Organization
- Jan 1, 2005
Earliest Phase 1 Sponsor(trial)
- Jan 1, 2006
Earliest Phase 3 Sponsor(trial)
- Jan 27, 2006
Mylan — NDA Secondary Org
- Jan 27, 2006
PHARMOBEDIENT — Marketing Organization
- Aug 3, 2006
Hi Tech Pharmaceuticals — Marketing Organization
- Aug 3, 2006
Rising Pharmaceuticals — Marketing Organization
- Aug 9, 2007
Apotex — Marketing Organization
2020s
- Jun 16, 2022
RiconPharma — Marketing Organization
Indications
Approved for
Mechanism of action
- Glucocorticoid receptorAGONIST
NR3C1 agonist
Approval history
- approvedPriority reviewSep 24, 1981
Chemistry & pharmacology
SMILES
CC1(C)O[C@@H]2C[C@H]3[C@@H]4C[C@H](F)C5=CC(=O)C=C[C@]5(C)[C@H]4[C@@H](O)C[C@]3(C)[C@@]2(O1)C(=O)CO- Mol. weight
- 434.4977 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Topical
- Availability
- Prescription Only
Oral
No
Parenteral
No
Topical
Yes
Sources
- WikipediaFlunisolide ↗
- NCATS78M02AA8KF ↗
- ChEMBLCHEMBL1512 ↗
Also known as
- 6 alpha-fluoro-11 beta,16 alpha,17,21- tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16, 17-acetal with acetone
- 6 alpha-fluorodihydroxy-16 alpha,17 alpha-isopropylidenedioxy-1,4-pregnadiene-3,20- dione
- aerobid
- aerobid
- aerobid
- aerospan
- aerospan
- aerospan hfa
- apo-flunisolide
- bronalide
- elan brand 1 of flunisolide
- elan brand 2 of flunisolide
- flunisolida
- flunisolida
- flunisolide
- flunisolide
- flunisolide
- flunisolide
- flunisolide
- flunisolide
- flunisolide
- flunisolide
- flunisolide
- flunisolide
- flunisolide
- flunisolide, (6beta,11beta,16alpha)-isomer
- flunisolide anhydrous
- flunisolide anhydrous
- flunisolide hemihydrate, (6alpha,11beta,16alpha)-isomer
- flunisolide hfa
- flunisolide hydrofluoroalkane
- flunisolidum
- flunisolidum
- inhacort
- nasalide
- nasalide
- nasalide
- nasalide
- nasalide
- nasarel
- nasarel
- nasarel
- ratio-flunisolide
- rhinalar
- rs-3999
- rs-3999
- rs-3999
- syntaris
- syntaris
- syntaris
- syntaris hayfever
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT02404103 | N/A | Mar 1, 2015 | Meda, University of Louisville |
| NCT00346775 | Phase 3 | May 1, 2006 | GlaxoSmithKline |
| NCT00203684 | Phase 1/Phase 2 (Phase 2) | Sep 13, 2005 | University of California, Los Angeles |
Organizations
Research & Development (4)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| GlaxoSmithKline | For profit | 1 | 1 | 1 | 2006 |
| Meda | For profit | 1 | 0 | 1 | 2015 |
| University of California, Los Angeles | Academic/Hospital | 1 | 1 | 1 | 2005 |
| University of Louisville | Academic/Hospital | 1 | 1 | 1 | 2015 |
Marketing (14)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Apotex | For profit | MKTG | Aug 9, 2007 |
| Apotex | For profit | SYN | Aug 9, 2007 |
| Bausch & Lomb | For profit | MKTG | Feb 20, 2002 |
| Bausch Health Companies | For profit | MKTG | Feb 20, 2002 |
| Hi Tech Pharmaceuticals | For profit | MKTG | Aug 3, 2006 |
| Ivax | For profit | NDA | Sep 24, 1981 |
| Ivax | For profit | NDA2 | Sep 24, 1981 |
| Mylan | For profit | NDA2 | Jan 27, 2006 |
| PHARMOBEDIENT | For profit | MKTG | Jan 27, 2006 |
| RiconPharma | For profit | MKTG | Jun 16, 2022 |
| Rising Pharmaceuticals | For profit | SYN | Aug 3, 2006 |
| Rising Pharmaceuticals | For profit | MKTG | Aug 3, 2006 |
| Roche | For profit | NDA2 | Aug 17, 1984 |
| Teva | For profit | NDA2 | Mar 8, 1995 |