prednicarbate
Trade name: dermatop
Approved
Sep 23, 1991
Prednicarbate is a relatively new topical corticosteroid drug. It is similar in potency to hydrocortisone. It has a favorable benefit-risk ratio, with an inflammatory action similar to that of a medium potency corticosteroid, but with a low potential to cause skin atrophy. DERMATOP Ointment (prednicarbate ointment) 0.1% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Like other topical corticosteroids, prednicarbate has anti-inflammatory, anti-pruritic 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 A2 inhibitory 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. Prednicarbate has a strong correlation between transactivation and glucocorticoid receptor binding. — NCATS
Clinical trial activity
5 trials · 3 clinical orgs · 2 marketing orgs
Earliest trial started May 1, 2004 (NCT00148746)
Timeline
1990s
- Sep 23, 1991
Bausch Health Companies — Earliest FDA Approval
- Sep 23, 1991
Bausch Health Companies — NDA Organization
- Oct 29, 1993
Bausch Health Companies — NDA Secondary Org
2010s
- Jan 1, 2013
Earliest Phase 1 Sponsor(trial)
Indications
Approved for
Mechanism of action
- Glucocorticoid receptorAGONIST
NR3C1 agonist
Approval history
- approvedSep 23, 1991
Chemistry & pharmacology
SMILES
CCOC(=O)O[C@@]1(CC[C@H]2[C@@H]3CCC4=CC(=O)C=C[C@]4(C)[C@H]3[C@@H](O)C[C@]12C)C(=O)COC(=O)CC- Mol. weight
- 488.5699 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
- WikipediaPrednicarbate ↗
- NCATSV901LV1K7D ↗
- ChEMBLCHEMBL1200386 ↗
Also known as
- batmen
- dermatop
- dermatop
- dermatop
- dermatop
- dermatop e emollient
- dermatop e emollient
- hoe 777
- hoe-777
- hoe-777
- hoe-777
- las189961
- peitel
- prednicarbate
- prednicarbate
- prednicarbate
- prednicarbate
- prednicarbate
- prednicarbate
- prednicarbate
- prednicarbate
- prednicarbate
- prednicarbate
- prednicarbate
- prednisolone-17-ethylcarbonate-21-propionate
- prednitop
- pregna-1,4-diene-3,20-dione, 17-((ethoxycarbonyl)oxy)-11-hydroxy-21-(1-oxopropoxy)-, (11beta)-
- s-770777
- s-770777
- s-77 0777
- s-77 0777
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT03399526 | Phase 1 | Feb 11, 2013 | Bayer |
| NCT01096472 | Phase 2 | Feb 1, 2010 | Almirall |
| NCT01102387 | Phase 2 | Feb 1, 2010 | Almirall |
| NCT01020994 | Phase 2 | Nov 1, 2009 | Almirall |
| NCT00148746 | N/A | May 1, 2004 | Technical University of Dresden |
Organizations
Research & Development (3)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Almirall | For profit | 3 | 3 | 1 | 2009 |
| Bayer | For profit | 1 | 1 | 1 | 2013 |
| Technical University of Dresden | Academic/Hospital | 1 | 1 | 1 | 2004 |
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Bausch Health Companies | For profit | NDA | Sep 23, 1991 |
| Bausch Health Companies | For profit | NDA2 | Oct 29, 1993 |
| Bausch Health Companies | For profit | SYN | Sep 23, 1991 |
| Fougera | For profit | MKTG | Sep 19, 2006 |