Desoximetasone

Generic Name: Desoximetasone

Brand Names: Desoxi, Topicort

Drug Type: Small Molecule

Chemical Formula: C_₂₂H_₂₉FO_₄

CAS Number: 382-67-2

Unique Ingredient Identifier: 4E07GXB7AU

Overview

A topical anti-inflammatory glucocorticoid used in dermatoses, skin allergies, psoriasis, etc.

Indication

For the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Associated Conditions

Allergic Contact Dermatitis
Atopic Dermatitis
Psoriasis
Psoriasis Vulgaris (Plaque Psoriasis)
Corticosteroid-responsive dermatoses

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Evaluating Treatment Resistant Dermatitis TaroIIR	2017/02/10	NCT03050294	Phase 4	Completed	Wake Forest University Health Sciences
Topical Scalp Psoriasis Study Evaluating Topicort Topical Spray	2016/12/07	NCT02985736	Phase 4	Completed	Psoriasis Treatment Center of Central New Jersey
Topical Psoriasis Study for Patients Receiving Biologic Therapy	2016/12/06	NCT02983981	Phase 4	Completed	Psoriasis Treatment Center of Central New Jersey
Study to Evaluate Efficacy and Safety of the Topical Product in Patients With Mild to Severe Scalp Psoriasis	2016/10/13	NCT02932462	Phase 3	Completed	Taro Pharmaceuticals USA
Efficacy and Safety of 0.25% Desoximetasone Cream (Topoxy®) in the Treatment of Scalp Psoriasis	2016/04/25	NCT02749656	Phase 3	UNKNOWN	Siriraj Hospital
Clinical Study to Evaluate the Efficacy and Safety of DSXS in Patients With Mild to Moderate Plaque Psoriasis	2015/12/01	NCT02618759	Phase 3	Completed	Taro Pharmaceuticals USA
Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Plaque Psoriasis	2015/11/10	NCT02601469	Phase 2	Completed	Taro Pharmaceuticals USA
Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone (DSXS) With Atopic Dermatitis	2015/11/03	NCT02595073	Phase 3	Completed	Taro Pharmaceuticals USA
Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Atopic Dermatitis	2015/11/03	NCT02595008	Phase 2	Completed	Taro Pharmaceuticals USA
Adrenal Suppression and Pharmacokinetics of Topicort® Spray, 0.25% in Pediatric Patients With Plaque Psoriasis	2015/01/16	NCT02340169	Phase 4	Completed	Taro Pharmaceuticals USA

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Desoximetasone	Physicians Total Care, Inc.	54868-2829	TOPICAL	0.5 mg in 1 g	1/12/2011
DESOXIMETASONE 0.05% / NIACINAMIDE 4%	Sincerus Florida, LLC	72934-5069	TOPICAL	0.05 g in 100 g	5/22/2019
desoximetasone	Zydus Lifesciences Limited	70771-1437	TOPICAL	2.5 mg in 1 g	11/5/2022
desoximetasone	Padagis Israel Pharmaceuticals Ltd	45802-496	TOPICAL	2.5 mg in 1 g	7/8/2019
DESOXIMETASONE 0.05% / HYDROQUINONE 6% / TRETINOIN 0.05%	Sincerus Florida, LLC	72934-6067	TOPICAL	0.05 g in 100 g	5/20/2019
Desoximetasone	Padagis Israel Pharmaceuticals Ltd	45802-495	TOPICAL	2.5 mg in 1 g	1/11/2017
Desoximetasone	Actavis Pharma, Inc.	0472-0479	TOPICAL	2.5 mg in 1 g	1/31/2020
Desoximetasone	GROUPE PARIMA INC	65179-501	TOPICAL	0.5 mg in 1 g	8/25/2016
Desoximetasone	Glenmark Pharmaceuticals Inc., USA	68462-531	TOPICAL	2.5 mg in 1 g	12/11/2018
Desoximetasone	Proficient Rx LP	71205-271	TOPICAL	2.5 mg in 1 g	4/1/2022

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
TOPICORT	bausch health, canada inc.	02221896	Cream - Topical	0.25 %	3/24/1997
TOPICORT GEL 0.05%	hoechst roussel canada inc.	01995065	Gel - Topical	.5 MG / G	12/31/1995
TOPICORT GEL 0.05%	hoechst canada inc.	00752541	Gel - Topical	.05 %	12/31/1988
TOPICORT MILD CREAM 0.5MG/GM	hoechst roussel canada inc.	01987526	Cream - Topical	.5 MG / G	12/31/1994
TOPICORT 0.25%	hoechst canada inc.	00420271	Cream - Topical	.25 %	12/31/1977
TOPICORT OINTMENT 2.5MG/GM	hoechst roussel canada inc.	01990942	Ointment - Topical	2.5 MG / G	12/31/1993
TOPICORT MILD .05%	hoechst canada inc.	00486450	Cream - Topical	.05 %	12/31/1980
DESOXI CREAM 0.25%	taropharma, a division of taro pharmaceuticals inc.	02239069	Cream - Topical	0.25 %	12/22/1999
TOPICORT CRM 2.5MG/GM	hoechst roussel canada inc.	01987844	Cream - Topical	2.5 MG / G	12/31/1994
TOPICORT	bausch health, canada inc.	02221926	Gel - Topical	0.05 %	12/4/1996

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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