Drugs / halobetasol propionate
halobetasol propionate
also known as
Ultravate · 21-chloro diflorasone · BMY-30056 · Bryhali · CGP-14,458 · Halobetasol · Halobetasol Propionate (HBP) · Halobetasol Propionate and Tazarotene Lotion · +10 more
Small molecule targets NR3C1 via activation
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | LEXETTE | — | 2021-08-18 | fda.gov ↗ |
| Label expansions (2) | US (FDA) | ULTRAVATE | — | 1991-12-31 – 2020-08-27 | fda.gov ↗ |
| Approved | US (FDA) | ULTRAVATE | — | 1990-12-17 | fda.gov ↗ |
Trials 17
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05282771 | Apr 2021 → Feb 2022 | psoriasis | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT00865267 | Dec 2003 | — | Actavis Inc. | Completed | No outcome recorded |
| Phase 25 trials · 1 met primary | ||||||
| Phase 2 | NCT03245385 | Jul 2017 → Feb 2018 | atopic eczema | Sun Pharmaceutical Industries, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT03298581 | Jan 2017 → Jan 2018 | psoriasis | Sun Pharmaceutical Industries, Inc. | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT02785185 | Jun → Dec 2016 | psoriasis | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02045277 | Feb → Nov 2014 | psoriasis | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01610596 | Nov 2011 → Feb 2012 | psoriasis | Therapeutics, Inc. | Completed | Met primary |
| Phase 37 trials · 2 met primary | ||||||
| Phase 3 | NCT05608499 | Oct 2022 → Apr 2024 | acne keloid | Icahn School of Medicine at Mount Sinai | Terminated | No outcome recorded |
| Phase 3 | NCT05203315 | Jan 2022 → Oct 2023 | psoriasis | Austin Institute for Clinical Research | Completed | No outcome recorded |
| Phase 3 | NCT02742441 | Jun 2016 → Feb 2017 | psoriasis | Therapeutics, Inc. | Completed | Met primary |
| Phase 3 | NCT02514577 | Nov 2015 → May 2017 | psoriasis | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02515097 | Nov 2015 → Mar 2017 | psoriasis | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02462083 | Aug 2015 → Jan 2017 | psoriasis | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02368210 | Jan → Jun 2015 | psoriasis | Therapeutics, Inc. | Completed | Met primary |
| Phase 43 trials | ||||||
| Phase 4 | NCT04720105 | Nov 2020 → Mar 2022 | psoriasis | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| Phase 4 | NCT03987763 | Oct 2019 → Nov 2026 expected | psoriasis | Bausch Health Americas, Inc. | Active not recruiting | No outcome recorded |
| Phase 4 | NCT03992261 | Jun → Dec 2019 | psoriasis | Mayne Pharma International Pty Ltd | Completed | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 1 | NCT03058744 Comparator | Apr 2015 → Dec 2016 | psoriasis | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT05348200 Comparator | Apr 2022 → Apr 2023 | hemorrhoid | Citius Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02785172 Comparator | Apr → Dec 2016 | psoriasis | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT04571151 Comparator | Jan → Nov 2021 | psoriasis | Skin Sciences, PLLC | Unknown | No outcome recorded |
| Phase 4 | NCT00990561 Comparator | Jul 2009 → Jun 2010 | psoriasis | University of California, San Francisco | Completed | No outcome recorded |
| Phase 4 | NCT01111123 Comparator | Jan 2009 → Mar 2010 | psoriasis | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2023-06-20 | Citius Pharmaceuticals, Inc. | Results Citius Pharmaceuticals Announces Positive Results from the Phase 2b Study of Halo-Lido (CITI-002) for the Treatment of Hemorrhoids citiuspharma.com ↗
The high dose formulation of CITI-002, a lidocaine and halobetasol propionate combination formulation, provided a meaningful reduction in symptom severity, as reported by patients, when compared to individual components alone. |
| 2021-09-22 | Mayne Pharma International Pty Ltd | Regulatory FDA Approves Lexette ® for Adolescent Plaque Psoriasis maynepharma.com ↗
Mayne Pharma is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved LEXETTE® (halobetasol propionate) foam, 0.05% for use in adolescents. |
| 2018-11-26 | Perrigo Company | Regulatory Perrigo Announces Tentative FDA Approval For The First To File Generic Version Of Ultravate® Lotion 0.05% perrigo.com ↗
Perrigo Company plc (NYSE; TASE: PRGO) today announced it has received tentative approval from the U.S. Food and Drug Administration for the first to file generic version of Ultravate ® Lotion (halobetasol propionate) 0.05%. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-06-20 | Citius Pharmaceuticals, Inc. | Citius Pharmaceuticals Announces Positive Results from the Phase 2b Study of Halo-Lido (CITI-002) for the Treatment of Hemorrhoids citiuspharma.com ↗ |
| 2021-09-22 | Mayne Pharma International Pty Ltd | FDA Approves Lexette ® for Adolescent Plaque Psoriasis maynepharma.com ↗ |
| 2018-11-26 | Perrigo Company | Perrigo Announces Tentative FDA Approval For The First To File Generic Version Of Ultravate® Lotion 0.05% perrigo.com ↗ |
| 2018-05-14 | Perrigo Company | Perrigo Confirms First To File Patent Challenge For Generic Version Of Ultravate® Lotion, 0.05% perrigo.com ↗ |
Evidence & citations 23 cited values
Every value below carries the sentence it was read from. 23 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | halobetasol propionate | “This is an investigator-masked, randomized, parallel, clinical study comparing the efficacy of once daily versus twice daily application of Ultravate® ointment (halobetasol...” NCT00990561 ↗18“The purpose of this study is to evaluate Halobetasol Propionate (HBP) foam, 0.05% in subjects aged 12 through less than 18 years with plaque psoriasis in order to check the...” NCT03992261 ↗ “A novel foam formulation of halobetasol propionate, 0.05% (HBP-Foam) has been developed to treat plaque psoriasis in patients who prefer a thermostable topical foam with low...” PMID 31424709 ↗ Aug 2019 “This study is to evaluate the safety, the systemic exposure of halobetasol propionate (HP), and the hypothalamic-pituitary-adrenal (HPA) axis suppression potential for...” NCT03987763 ↗ “Duobrii® lotion (halobetasol propionate \[HP\] and tazarotene \[Taz\] 0.01%/0.045%) is currently on the market for the treatment of moderate to severe stable plaque psoriasis,...” NCT05203315 ↗ “IDP-118 lotion (halobetasol propionate 0.01%, tazarotene 0.045%) will be applied topically on the affected area once daily for 8 weeks and then as needed once daily for up to 1 year.” NCT02462083 ↗ “Participants will apply IDP-122 Lotion (halobetasol propionate \[HP\] 0.01%) topically once daily for 8 weeks.” NCT02515097 ↗ “Lac-Hydrin lotion (ammonium lactate lotion 12%) ; UItravate ointment (halobetasol propionate ointment 0.05%)” NCT01111123 ↗ “Single therapy cream containing Halobetasol Propionate (low-strength). HPB is a topical corticosteroid.” NCT05348200 ↗ “Halobetasol propionate (HP) 0.05% is a highly effective short-term treatment for plaque psoriasis.” PMID 30207807 ↗ Nov 2018 “Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects” NCT00865267 ↗ |
| Known as | 21-chloro diflorasone | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200908 ↗ |
| Known as | BMY-30056 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200908 ↗ |
| Known as | Bryhali | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05608499 ↗ |
| Known as | CGP-14,458 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200908 ↗ |
| Known as | Halobetasol | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200908 ↗ |
| Known as | Halobetasol Propionate (HBP) | “Halobetasol Propionate (HBP)” NCT05348200 ↗ |
| Known as | Halobetasol Propionate and Tazarotene Lotion | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05282771 ↗ |
| Known as | Halobetasol propionate component of duobrii | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200908 ↗ |
| Known as | Halobetasol propionate component of idp-118 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200908 ↗ |
| Known as | HBP | “The purpose of this study is to evaluate Halobetasol Propionate (HBP) foam, 0.05% in subjects aged 12 through less than 18 years with plaque psoriasis in order to check the...” NCT03992261 ↗ |
| Known as | HBP-Foam | “A novel foam formulation of halobetasol propionate, 0.05% (HBP-Foam) has been developed to treat plaque psoriasis in patients who prefer a thermostable topical foam with low...” PMID 31424709 ↗ Aug 2019 |
| Known as | IDP-122 | “Participants will apply IDP-122 Lotion (halobetasol propionate \[HP\] 0.01%) topically once daily for 8 weeks.” NCT02515097 ↗ |
| Known as | IDP-122 Lotion | “IDP-122 Lotion (halobetasol propionate” NCT02514577 ↗ |
| Known as | Jemdel | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200908 ↗ |
| Known as | Lexette | “The study drugs that will be used in this study are Lexette® (0.05% Halobetasol propionate foam) and Sorilux® (calcipotriene foam).” NCT04571151 ↗ |
| Known as | Ulobetasol | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200908 ↗ |
| Known as | Ulobetasol propionate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200908 ↗ |
| Known as | Ultravate | “This is an investigator-masked, randomized, parallel, clinical study comparing the efficacy of once daily versus twice daily application of Ultravate® ointment (halobetasol...” NCT00990561 ↗3“ammonium lactate lotion 12% (Lac-Hydrin) and halobetasol propionate ointment 0.05% (Ultravate)” NCT01111123 ↗ |
| Action | Activate | “Glucocorticoid receptor agonist” CHEMBL1200908 ↗ |
| Modality | Small molecule | — CHEMBL1200908 ↗ |
| Route | Topical | “Topically Delivered Halobetasol Propionate Ointment” NCT00865267 ↗ |
| Target | NR3C1 | “Glucocorticoid receptor agonist” CHEMBL1200908 ↗ |