Drugs / Desoximetasone
Desoximetasone
also known as
Topicort · A-41-304 · Desoximetasona · Desoxymethasone · HOE 304 · J83.644C · NSC-759189 · R 2113 · +4 more
Small molecule targets NR3C1 via activation
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed psoriasis 1 milestone | |||||
| Filed | US (FDA) | — | psoriasis | 2014-07-30 | “announced that it has filed with the U.S. Food and Drug Administration (FDA) an Abbreviated New Drug Application for desoximetasone topical spray 0.25%” perrigo.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Label expansion | US (FDA) | TOPICORT | — | 2021-10-07 | fda.gov ↗ |
| Approved | US (FDA) | TOPICORT | — | 1977-02-28 | fda.gov ↗ |
Trials 10
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials · 1 met primary | ||||||
| Phase 2 | NCT01043393 | Feb → Jun 2010 | psoriasis | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01018134 | Nov 2009 → May 2010 | psoriasis | Sun Pharmaceutical Industries, Inc. | Completed | Met primary |
| Phase 34 trials · 2 met primary · 1 missed | ||||||
| Phase 3 | NCT02749656 | Jan 2016 → Jan 2018 | psoriasis | Siriraj Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT02595073 | Sep 2015 → Jan 2017 | atopic eczema | Sun Pharmaceutical Industries, Inc. | Completed | Missed primary |
| Phase 3 | NCT01206660 | Aug → Dec 2010 | psoriasis | Sun Pharmaceutical Industries, Inc. | Completed | Met primary |
| Phase 3 | NCT01206387 | Aug → Dec 2010 | psoriasis | Sun Pharmaceutical Industries, Inc. | Completed | Met primary |
| Phase 44 trials | ||||||
| Phase 4 | NCT03050294 | Feb → Jun 2017 | atopic eczema, psoriasis | Wake Forest University Health Sciences | Completed | No outcome recorded |
| Phase 4 | NCT02985736 | Sep 2016 → Jan 2017 | psoriasis | Psoriasis Treatment Center of Central New Jersey | Completed | No outcome recorded |
| Phase 4 | NCT02983981 | Mar → Sep 2016 | psoriasis | Psoriasis Treatment Center of Central New Jersey | Completed | No outcome recorded |
| Phase 4 | NCT02340169 | Jan 2015 → Nov 2019 | psoriasis | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2018-03-18 | Lupin Limited | Regulatory Lupin receives FDA approval for generic Topicort Topical Spray, 0.25% lupin.com ↗
Lupin announced that it has received final approval for its Desoximetasone Topical Spray, 0.25%, 30 ml, 50 ml, and 100 ml from the United States Food and Drug Administration (FDA) |
| 2017-06-22 | Lupin Limited | Regulatory Lupin launches generic Topicort® LP Emollient Cream and Topicort® Cream in the US lupin.com ↗
Mumbai, Baltimore: Pharma Major Lupin Limited (Lupin) announced today the launch of its Desoximetasone Cream USP, 0.05% and Desoximetasone Cream USP, 0.25% having received an approval from the United States Food and Drug Administration (FDA) earlier. |
| 2017-01-24 | Perrigo Company | Regulatory Perrigo Announces FDA Approval Of Its First-To-File AB Rated Generic Version Of Topicort® Spray, 0.25% perrigo.com ↗
Perrigo Company plc (NYSE; TASE: PRGO) today announced it has received U.S. Food and Drug Administration approval for its first-to-file Abbreviated New Drug Application referencing Taro Pharmaceuticals USA Inc.'s Topicort ® Spray, 0.25% (desoximetasone topical spray, 0.25%). |
| 2017-01-11 | Lupin Limited | Regulatory Lupin Receives FDA Approval for Generic Topicort® LP Emollient Cream, 0.05% and Topicort® Cream, 0.25% lupin.com ↗ |
| 2016-12-13 | Lupin Limited | Regulatory Lupin Receives FDA Approval for Generic Topicort® Ointment, 0.05% lupin.com ↗ |
| 2014-07-30 | Perrigo Company | Regulatory Perrigo Confirms First To File Patent Challenge For Generic Version Of Topicort® Topical Spray 0.25% perrigo.com ↗
Perrigo Company (NYSE: PRGO;TASE) announced that it has filed with the U.S. Food and Drug Administration (FDA) an Abbreviated New Drug Application for desoximetasone topical spray 0.25% and that it has notified Taro Pharmaceuticals U.S.A. , Inc., the owner of the Reference Listed Drug of its filing. |
| 2006-01-10 | Perrigo Company | Regulatory Perrigo Company Announces FDA Approval for Desoximetasone Gel perrigo.com ↗
The Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to manufacture and market Desoximetasone Gel USP, 0.05%. |
All press releases naming this drug 9 releases
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Desoximetasone | “An Open-Label, Observational Study Evaluating Topicort® Topical Spray 0.25% (Desoximetasone) BID in Psoriasis Patients Being Treated With Biologic Agents” NCT02983981 ↗9“An Open-Label, Study Evaluating Topicort® Topical Spray 0.25% (Desoximetasone) in Patients With Scalp Psoriasis” NCT02985736 ↗ “Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone (DSXS) With Atopic Dermatitis” NCT02595073 ↗ |
| Known as | A-41-304 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1766 ↗ |
| Known as | Desoximetasona | ChEMBL registry synonym — accepted as the source's own label CHEMBL1766 ↗ |
| Known as | Desoxymethasone | ChEMBL registry synonym — accepted as the source's own label CHEMBL1766 ↗ |
| Known as | HOE 304 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1766 ↗ |
| Known as | J83.644C | ChEMBL registry synonym — accepted as the source's own label CHEMBL1766 ↗ |
| Known as | NSC-759189 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1766 ↗ |
| Known as | R 2113 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1766 ↗ |
| Known as | Stiedex | ChEMBL registry synonym — accepted as the source's own label CHEMBL1766 ↗ |
| Known as | Stiedex lp | ChEMBL registry synonym — accepted as the source's own label CHEMBL1766 ↗ |
| Known as | Stiedex lpn | ChEMBL registry synonym — accepted as the source's own label CHEMBL1766 ↗ |
| Known as | Topicort | “An Open-Label, Observational Study Evaluating Topicort® Topical Spray 0.25% (Desoximetasone) BID in Psoriasis Patients Being Treated With Biologic Agents” NCT02983981 ↗2“An Open-Label, Study Evaluating Topicort® Topical Spray 0.25% (Desoximetasone) in Patients With Scalp Psoriasis” NCT02985736 ↗ “Topicort® (desoximetasone) Topical Spray, 0.25% applied to affected areas twice a day for 28 days” NCT02340169 ↗ |
| Known as | Topicort lp | ChEMBL registry synonym — accepted as the source's own label CHEMBL1766 ↗ |
| Action | Activate | “Glucocorticoid receptor agonist” CHEMBL1766 ↗ |
| Modality | Small molecule | — CHEMBL1766 ↗ |
| Route | Topical | “Desoximetasone topical spray 0.05% administered to affected area once daily” NCT01018134 ↗ |
| Target | NR3C1 | “Glucocorticoid receptor agonist” CHEMBL1766 ↗ |