alclometasone

Trade name: aclovate

Small moleculeapproved

Approved

Dec 14, 1982

Alclometasone is synthetic glucocorticoid steroid for topical use. Alclometasone dipropionate cream USP and alclometasone dipropionate ointment USP are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. It may be used in pediatric patients 1 year of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established. Like other topical corticosteroids, alclometasone dipropionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. Alclometasone initially binds the corticosteroid receptor. This complex migrates to the nucleus where it binds to different glucocorticoid response elements on the DNA. This in turn enhances and represses various genes, especially those involved in inflammatory pathways. — NCATS

Clinical trial activity

2 trials · 2 clinical orgs · 3 marketing orgs

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

Earliest trial started Sep 1, 2006 (NCT02075632)

Timeline

1980s

  1. Dec 14, 1982

    Fougera — Earliest FDA Approval

  2. Dec 14, 1982

    Fougera — NDA Organization

  3. Dec 14, 1982

    Fougera — NDA Secondary Org

2000s

  1. Jul 29, 2004

    Taro Pharmaceuticals — Marketing Organization

  2. Jul 12, 2005

    Fougera — Marketing Organization

  3. Jan 1, 2006

    Earliest Phase 2 Sponsor(trial)

  4. Jun 23, 2009

    Glenmark Pharmaceuticals — Marketing Organization

Indications

Mechanism of action

Approval history

  • approvedDec 14, 1982

Chemistry & pharmacology

Loading structure…

SMILES

C[C@@H]1C[C@H]2[C@@H]3[C@H](Cl)CC4=CC(=O)C=C[C@]4(C)[C@H]3[C@@H](O)C[C@]2(C)[C@@]1(O)C(=O)CO
Mol. weight
408.916 g/mol
Lipinski Ro5
1 violation(s)
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

  • (7alpha,11beta,16alpha)-7-chloro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione
  • (7alpha,11beta,16alpha)-7-chloro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione
  • (7 alpha,11 beta,16 alpha)-7-chloro-11-hydroxy-16-methyl-17,21-bis(1- oxopropoxy)pregna-1,4-diene-3,20-dione
  • 7 alpha-chloro-16 alpha-methylprednisolone 17,21-dipropionate
  • 7α-chloro-16α-methylprednisolone
  • 7α-chloro-16α-methylprednisolone
  • aclosone
  • aclovate
  • aclovate
  • aclovate
  • aclovate
  • aclovate
  • alclometasone
  • alclometasone
  • alclometasone
  • alclometasone
  • alclometasone
  • alclometasone
  • alclometasone
  • alclometasone
  • alclometasone dipropionate
  • alclometasone dipropionate
  • alclometasone dipropionate
  • alclometasone dipropionate
  • alclometasone dipropionate
  • alclometasone dipropionate
  • alclometasone dipropionate
  • alclomethasone
  • delonal
  • logoderm
  • modrasone
  • modrasone
  • modrasone
  • sch 22219
  • sch-22219
  • sch-22219

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT01465802Phase 2Dec 1, 2011Pfizer
NCT02075632Phase 2Sep 1, 2006GlaxoSmithKline
Showing 2 of 2 trials
Page 1 / 1

Organizations

Research & Development (2)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GlaxoSmithKlineFor profit1112006
PfizerFor profit1112011
2 organizations
Page 1 / 1

Marketing (6)

OrganizationOrg typeRelationshipDate
FougeraFor profitNDADec 14, 1982
FougeraFor profitNDA2Dec 14, 1982
FougeraFor profitMKTGJul 12, 2005
Glenmark PharmaceuticalsFor profitMKTGJun 23, 2009
Glenmark PharmaceuticalsFor profitSYNJun 23, 2009
Taro PharmaceuticalsFor profitMKTGJul 29, 2004