ulobetasol propionate
Trade name: Ultravate
Approved
Dec 17, 1990
Ulobetasol propionate, also known as halobetasol propionate and sold under the brand name Ultravate among others, is a synthetic glucocorticoid corticosteroid and a corticosteroid ester. — Wikipedia
Clinical trial activity
10 trials · 4 clinical orgs · 14 marketing orgs
Earliest trial started Jun 1, 2012 (NCT01670513)
Timeline
1990s
- Dec 17, 1990
Sun Pharmaceuticals — Earliest FDA Approval
- Dec 17, 1990
Sun Pharmaceuticals — NDA Secondary Org
- Dec 17, 1990
Sun Pharmaceuticals — NDA Organization
2000s
- Dec 16, 2004
Fougera — Marketing Organization
- Dec 16, 2004
Perrigo — Marketing Organization
- Dec 16, 2004
Taro Pharmaceuticals — Marketing Organization
- Dec 16, 2004
Padagis Us — Marketing Organization
- Jun 14, 2005
G & W Laboratories Inc. — Marketing Organization
- Jun 14, 2005
Cosette — Marketing Organization
- Jun 14, 2005
ACP Nimble — Marketing Organization
2010s
- Jan 1, 2012
Dow Pharmaceutical Sciences — Earliest Phase 1 Sponsor(trial)
- Jan 1, 2013
Earliest Phase 3 Sponsor(trial)
- Jan 1, 2014
Bausch Health Companies — Earliest Phase 2 Sponsor(trial)
- Mar 20, 2018
Pharmaceutical Associates — Marketing Organization
- Mar 20, 2018
Teligent Pharmaceuticals — Marketing Organization
- May 24, 2018
Mayne Pharma — NDA Secondary Org
- Nov 6, 2018
Dow Pharmaceutical Sciences — NDA Secondary Org
- Nov 6, 2018
Bausch Health Companies — NDA Secondary Org
2020s
- Oct 6, 2020
Quagen Pharma — Marketing Organization
- Apr 20, 2023
Sun Pharmaceuticals — Marketing Organization
Indications
Approved for
Mechanism of action
- Glucocorticoid receptorAGONIST
NR3C1 agonist
Combination products
duobrii
with tazarotene
Approval history
- approvedDec 17, 1990
Chemistry & pharmacology
SMILES
CCC(=O)O[C@]1(C(=O)CCl)[C@@H](C)C[C@H]2[C@@H]3C[C@H](F)C4=CC(=O)C=C[C@]4(C)[C@@]3(F)[C@@H](O)C[C@@]21C- Mol. weight
- 484.97 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
- WikipediaUlobetasol propionate ↗
- ChEMBLCHEMBL1200908 ↗
Also known as
- 000-0551
- halobetasol propionate
- halobetasol propionate
- halobetasol propionate
- halobetasol propionate
- halobetasol propionate
- halobetasol propionate
- idp-118
- miracorten
- ulobetasol propionate
- ulobetasol propionate
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05608499 | Phase 3 | Oct 4, 2022 | Bausch Health Companies, Icahn School of Medicine at Mount Sinai |
| NCT02785172 | Phase 2 | Apr 1, 2016 | Bausch Health Companies |
| NCT02785159 | Phase 2 | Feb 1, 2016 | Bausch Health Companies |
| NCT02462083 | Phase 3 | Aug 11, 2015 | Bausch Health Companies, Dow Pharmaceutical Sciences |
| NCT02462070 | Phase 3 | Aug 11, 2015 | Bausch Health Companies, Dow Pharmaceutical Sciences |
| NCT02462122 | Phase 3 | Jul 1, 2015 | Bausch Health Companies, Dow Pharmaceutical Sciences |
| NCT02045277 | Phase 2 | Feb 1, 2014 | Bausch Health Companies, Dow Pharmaceutical Sciences |
| NCT01882647 | Phase 3 | Jun 1, 2013 | Therapeutics, Inc. |
| NCT01871402 | Phase 3 | May 1, 2013 | Therapeutics, Inc. |
| NCT01670513 | Phase 1/Phase 2 (Phase 2) | Jun 1, 2012 | Dow Pharmaceutical Sciences |
Organizations
Research & Development (4)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Bausch Health Companies | For profit | 7 | 6 | 2 | 2014 |
| Dow Pharmaceutical Sciences | For profit | 5 | 1 | 2 | 2012 |
| Therapeutics, Inc. | For profit | 2 | 2 | 1 | 2013 |
| Icahn School of Medicine at Mount Sinai | Academic/Hospital | 1 | 1 | 1 | 2022 |
Marketing (20)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| ACP Nimble | For profit | MKTG | Jun 14, 2005 |
| Bausch Health Companies | For profit | NDA2 | Nov 6, 2018 |
| Cosette | For profit | MKTG | Jun 14, 2005 |
| Dow Pharmaceutical Sciences | For profit | NDA2 | Nov 6, 2018 |
| Fougera | For profit | MKTG | Dec 16, 2004 |
| G & W Laboratories Inc. | For profit | SYN | Sep 7, 2006 |
| G & W Laboratories Inc. | For profit | MKTG | Jun 14, 2005 |
| Mayne Pharma | For profit | NDA2 | May 24, 2018 |
| Padagis Us | For profit | MKTG | Dec 16, 2004 |
| Perrigo | For profit | MKTG | Dec 16, 2004 |
| Pharmaceutical Associates | For profit | MKTG | Mar 20, 2018 |
| Quagen Pharma | For profit | MKTG | Oct 6, 2020 |
| Sun Pharmaceuticals | For profit | NDA2 | Dec 17, 1990 |
| Sun Pharmaceuticals | For profit | SYN | Nov 6, 2015 |
| Sun Pharmaceuticals | For profit | MKTG | Apr 20, 2023 |
| Sun Pharmaceuticals | For profit | NDA | Dec 17, 1990 |
| Taro Pharmaceuticals | For profit | SYN | Apr 20, 2023 |
| Taro Pharmaceuticals | For profit | MKTG | Dec 16, 2004 |
| Teligent Pharmaceuticals | For profit | MKTG | Mar 20, 2018 |
| Teligent Pharmaceuticals | For profit | SYN | Mar 20, 2018 |