flunisolide

Trade name: nasalide

Small moleculeapproved

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

Phase 1
1
Phase 2
2
Phase 3
1
Phase 4
0

Earliest trial started Sep 13, 2005 (NCT00203684)

Timeline

1980s

  1. Sep 24, 1981

    Ivax — Earliest FDA Approval

  2. Sep 24, 1981

    Ivax — NDA Organization

  3. Sep 24, 1981

    Ivax — NDA Secondary Org

  4. Aug 17, 1984

    Roche — NDA Secondary Org

1990s

  1. Mar 8, 1995

    Teva — NDA Secondary Org

2000s

  1. Feb 20, 2002

    Bausch Health Companies — Marketing Organization

  2. Feb 20, 2002

    Bausch & Lomb — Marketing Organization

  3. Jan 1, 2005

    Earliest Phase 1 Sponsor(trial)

  4. Jan 1, 2006

    Earliest Phase 3 Sponsor(trial)

  5. Jan 27, 2006

    Mylan — NDA Secondary Org

  6. Jan 27, 2006

    PHARMOBEDIENT — Marketing Organization

  7. Aug 3, 2006

    Hi Tech Pharmaceuticals — Marketing Organization

  8. Aug 3, 2006

    Rising Pharmaceuticals — Marketing Organization

  9. Aug 9, 2007

    Apotex — Marketing Organization

2020s

  1. Jun 16, 2022

    RiconPharma — Marketing Organization

Indications

Mechanism of action

Approval history

  • approvedPriority reviewSep 24, 1981

Chemistry & pharmacology

Loading structure…

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

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 IDPhaseStart dateSponsor(s)
NCT02404103N/AMar 1, 2015Meda, University of Louisville
NCT00346775Phase 3May 1, 2006GlaxoSmithKline
NCT00203684Phase 1/Phase 2 (Phase 2)Sep 13, 2005University of California, Los Angeles
Showing 3 of 3 trials
Page 1 / 1

Organizations

Research & Development (4)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GlaxoSmithKlineFor profit1112006
MedaFor profit1012015
University of California, Los AngelesAcademic/Hospital1112005
University of LouisvilleAcademic/Hospital1112015
4 organizations
Page 1 / 1

Marketing (14)

OrganizationOrg typeRelationshipDate
ApotexFor profitMKTGAug 9, 2007
ApotexFor profitSYNAug 9, 2007
Bausch & LombFor profitMKTGFeb 20, 2002
Bausch Health CompaniesFor profitMKTGFeb 20, 2002
Hi Tech PharmaceuticalsFor profitMKTGAug 3, 2006
IvaxFor profitNDASep 24, 1981
IvaxFor profitNDA2Sep 24, 1981
MylanFor profitNDA2Jan 27, 2006
PHARMOBEDIENTFor profitMKTGJan 27, 2006
RiconPharmaFor profitMKTGJun 16, 2022
Rising PharmaceuticalsFor profitSYNAug 3, 2006
Rising PharmaceuticalsFor profitMKTGAug 3, 2006
RocheFor profitNDA2Aug 17, 1984
TevaFor profitNDA2Mar 8, 1995