prednicarbate

Trade name: dermatop

Small moleculeapproved

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

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

Earliest trial started May 1, 2004 (NCT00148746)

Timeline

1990s

  1. Sep 23, 1991

    Bausch Health Companies — Earliest FDA Approval

  2. Sep 23, 1991

    Bausch Health Companies — NDA Organization

  3. Oct 29, 1993

    Bausch Health Companies — NDA Secondary Org

2000s

  1. Sep 19, 2006

    Fougera — Marketing Organization

  2. Jan 1, 2009

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2013

    Earliest Phase 1 Sponsor(trial)

Indications

Mechanism of action

Approval history

  • approvedSep 23, 1991

Chemistry & pharmacology

Loading structure…

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

Prodrug

Sources

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 IDPhaseStart dateSponsor(s)
NCT03399526Phase 1Feb 11, 2013Bayer
NCT01096472Phase 2Feb 1, 2010Almirall
NCT01102387Phase 2Feb 1, 2010Almirall
NCT01020994Phase 2Nov 1, 2009Almirall
NCT00148746N/AMay 1, 2004Technical University of Dresden
Showing 5 of 5 trials
Page 1 / 1

Organizations

Research & Development (3)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AlmirallFor profit3312009
BayerFor profit1112013
Technical University of DresdenAcademic/Hospital1112004
3 organizations
Page 1 / 1

Marketing (4)

OrganizationOrg typeRelationshipDate
Bausch Health CompaniesFor profitNDASep 23, 1991
Bausch Health CompaniesFor profitNDA2Oct 29, 1993
Bausch Health CompaniesFor profitSYNSep 23, 1991
FougeraFor profitMKTGSep 19, 2006