halcinonide

Trade name: halog

Small moleculeapproved

Approved

Nov 27, 1974

Halcinonide is one of the available highly potent topical cor¬ticosteroids. It is a derivative of hydrocortisone and contains important modifications in its structure that alter its absorption, potency, and adverse effects compared with hydrocortisone. Halcinonide—along with desoximetasone, betamethasone, fluocinonide, and diflorasone diacetate—is classified as a Class II potency corticosteroid. Although similar in strength, halcinonide in Halog (the only topical product available that contains halcinonide) differs from many other compounds of this class in the formulation. Halcinonide cream is formulated in a biphasic base that allows for immediate-release of halcinonide upon application to the skin, followed by a delayed and sustained release of halcinonide over time. This “dual formulation” strategy allows for prolonged halcinonide activity. The formulation of halcinonide cream contains microcrystals of halcinonide. An equilibrium is established between dissolved halcinonide in the cream and non-dissolved halcinonide in the microcrystals. As soluble hal¬cinonide enters the skin, additional quantities of halcinonide from the microcrystals become available as a new equilibrium is established. This dynamic equilibrium serves to maintain a sustained level of halcinonide well beyond the time of application. — NCATS

Clinical trial activity

0 trials · 0 clinical orgs · 7 marketing orgs

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

Timeline

1970s

  1. Nov 27, 1974

    Sun Pharmaceuticals — Earliest FDA Approval

  2. Nov 27, 1974

    Sun Pharmaceuticals — NDA Secondary Org

  3. Nov 27, 1974

    Sun Pharmaceuticals — NDA Organization

  4. Jun 15, 1977

    Squibb — NDA Secondary Org

2010s

  1. Aug 12, 2019

    Mylan — Marketing Organization

2020s

  1. Sep 8, 2021

    Glasshouse Pharmaceuticals — Marketing Organization

  2. Sep 8, 2021

    Chartwell Pharmaceuticals — Marketing Organization

  3. May 29, 2024

    Encube Ethicals Pvt. Ltd. — Marketing Organization

Indications

Mechanism of action

Approval history

  • approvedNov 27, 1974

Chemistry & pharmacology

Loading structure…

SMILES

CC1(C)O[C@@H]2C[C@H]3[C@@H]4CCC5=CC(=O)CC[C@]5(C)[C@@]4(F)[C@@H](O)C[C@]3(C)[C@@]2(O1)C(=O)CCl
Mol. weight
454.959 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

Also known as

  • (4as,4br,5s,6as,6bs,9ar,10as,10bs)-6b-(chloroacetyl)-4b-fluoro-5-hydroxy-4a,6a,8,8-tetramethyl-3,4,4a,4b,5,6,6a,6b,9a,10,10a,10b,11,12-tetradecahydro-2h-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-2-one
  • (4as,4br,5s,6as,6bs,9ar,10as,10bs)-6b-(chloroacetyl)-4b-fluoro-5-hydroxy-4a,6a,8,8-tetramethyl-3,4,4a,4b,5,6,6a,6b,9a,10,10a,10b,11,12-tetradecahydro-2h-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-2-one
  • alcinonide
  • halciderm
  • halcimat
  • halcinonid
  • halcinonid
  • halcinonida
  • halcinonida
  • halcinonide
  • halcinonide
  • halcinonide
  • halcinonide
  • halcinonide
  • halcinonide
  • halcinonide
  • halcinonide
  • halcinonide
  • halcinonide
  • halcinonidum
  • halcinonidum
  • halog
  • halog
  • halog
  • halog
  • halog-e
  • halog-e
  • so-18566
  • so-18566
  • sq-18566
  • sq-18566

Organizations

Marketing (8)

OrganizationOrg typeRelationshipDate
Bristol-Myers SquibbFor profitNDA2
Chartwell PharmaceuticalsFor profitMKTGSep 8, 2021
Encube Ethicals Pvt. Ltd.For profitMKTGMay 29, 2024
Glasshouse PharmaceuticalsFor profitMKTGSep 8, 2021
MylanFor profitMKTGAug 12, 2019
SquibbFor profitNDA2Jun 15, 1977
Sun PharmaceuticalsFor profitNDA2Nov 27, 1974
Sun PharmaceuticalsFor profitNDANov 27, 1974