alclometasone
Trade name: aclovate
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
Earliest trial started Sep 1, 2006 (NCT02075632)
Timeline
1980s
2000s
- Jul 29, 2004
Taro Pharmaceuticals — Marketing Organization
- Jul 12, 2005
Fougera — Marketing Organization
- Jan 1, 2006
Earliest Phase 2 Sponsor(trial)
- Jun 23, 2009
Glenmark Pharmaceuticals — Marketing Organization
Indications
Approved for
Mechanism of action
- Glucocorticoid receptorAGONIST
NR3C1 agonist
Approval history
- approvedDec 14, 1982
Chemistry & pharmacology
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
- WikipediaAlclometasone ↗
- NCATS136H45TB7B ↗
- ChEMBLCHEMBL1201361 ↗
- ChEMBLCHEMBL1200989 ↗
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 ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT01465802 | Phase 2 | Dec 1, 2011 | Pfizer |
| NCT02075632 | Phase 2 | Sep 1, 2006 | GlaxoSmithKline |
Organizations
Research & Development (2)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| GlaxoSmithKline | For profit | 1 | 1 | 1 | 2006 |
| Pfizer | For profit | 1 | 1 | 1 | 2011 |
Marketing (6)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Fougera | For profit | NDA | Dec 14, 1982 |
| Fougera | For profit | NDA2 | Dec 14, 1982 |
| Fougera | For profit | MKTG | Jul 12, 2005 |
| Glenmark Pharmaceuticals | For profit | MKTG | Jun 23, 2009 |
| Glenmark Pharmaceuticals | For profit | SYN | Jun 23, 2009 |
| Taro Pharmaceuticals | For profit | MKTG | Jul 29, 2004 |