clocortolone
Trade name: cloderm
Approved
Aug 22, 1977
Clocortolone (used in form of pivalate prodrug) is a topical glucocorticoid that was approved by FDA for the treatment of corticosteroid-responsive skin disorders. The drug exerts its anti-inflammatory action by binding to glucocorticoid receptor which results in regulation of the expression of proinflammatory cytokines and further antiproliferative, immunosuppressive, and initial vasoconstrictive effects. — NCATS
Clinical trial activity
2 trials · 3 clinical orgs · 4 marketing orgs
Earliest trial started Oct 1, 2012 (NCT01714544)
Timeline
1970s
- Aug 22, 1977
Epi Health — Earliest FDA Approval
- Aug 22, 1977
Epi Health — NDA Secondary Org
- Aug 22, 1977
Epi Health — NDA Organization
- Aug 22, 1977
LEGACY PHARMA — Marketing Organization
2010s
- Jan 1, 2018
Taro Pharmaceuticals — Earliest Phase 1 Sponsor(trial)
2020s
- Apr 21, 2020
Taro Pharmaceuticals — Marketing Organization
- Apr 21, 2020
Sun Pharmaceuticals — Marketing Organization
Indications
Approved for
Studied for
Mechanism of action
- Glucocorticoid receptorAGONIST
NR3C1 agonist
Approval history
- approvedAug 22, 1977
Chemistry & pharmacology
SMILES
C[C@@H]1C[C@H]2[C@@H]3C[C@H](F)C4=CC(=O)C=C[C@]4(C)[C@@]3(Cl)[C@@H](O)C[C@]2(C)[C@H]1C(=O)CO- Mol. weight
- 410.907 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
- WikipediaClocortolone ↗
- NCATSN8ZUB7XE0H ↗
- ChEMBLCHEMBL1200975 ↗
Also known as
- 9 alpha-chloro-6 alpha-fluoro-11 beta,21- dihydroxy-16 alpha-methylpregna-1,4-diene-3,20- dione 21-pivalate
- 9-chloro-6alpha-fluoro-11beta,21-dihydroxy-16alpha-methyl-1,4-pregnadien-3,20-dione
- 9-chloro-6alpha-fluoro-11beta,21-dihydroxy-16alpha-methyl-1,4-pregnadien-3,20-dione
- 9-chloro-6 alpha-fluoro-11 beta,21-dihydroxy- 16 alpha-methylpregnadiene-3,20-dione 21-acetate
- 9-chloro-6alpha-fluoro-16alpha-methyl-1,4-pregnadiene-11beta,21-diol-3,20-dione
- 9-chloro-6alpha-fluoro-16alpha-methyl-1,4-pregnadiene-11beta,21-diol-3,20-dione
- cl 68
- clocortolon
- clocortolon
- clocortolona
- clocortolona
- clocortolone
- clocortolone
- clocortolone
- clocortolone
- clocortolone
- clocortolone acetate
- clocortolone pivalate
- clocortolone pivalate
- clocortolone pivalate
- clocortolone pivalate
- clocortolone pivalate
- clocortolone pivalate
- clocortolone pivalate
- clocortolone pivalate
- clocortolone trimethylacetate
- clocortolone trimethylacetate
- clocortolonum
- clocortolonum
- cloderm
- cloderm
- cloderm
- cloderm
- cloderm
- purantix
- sh-863
- sh-863
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT04358770 | Phase 1 | Mar 2, 2018 | DFW Clinical Research, Taro Pharmaceuticals |
| NCT01714544 | Phase 4 | Oct 1, 2012 | Dr. Reddy's Laboratories |
Organizations
Research & Development (3)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| DFW Clinical Research | For profit | 1 | 0 | 1 | 2018 |
| Dr. Reddy's Laboratories | For profit | 1 | 1 | 1 | 2012 |
| Taro Pharmaceuticals | For profit | 1 | 1 | 1 | 2018 |
Marketing (5)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Epi Health | For profit | NDA2 | Aug 22, 1977 |
| Epi Health | For profit | NDA | Aug 22, 1977 |
| LEGACY PHARMA | For profit | MKTG | Aug 22, 1977 |
| Sun Pharmaceuticals | For profit | MKTG | Apr 21, 2020 |
| Taro Pharmaceuticals | For profit | MKTG | Apr 21, 2020 |