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Halobetasol 0.05% ointment
Halobetasol 0.05% ointment is a Small molecule drug developed by Patel, Rita Vikram, M.D.. It is currently in Phase 1 development.
Halobetasol 0.05% ointment is a small molecule glucocorticoid receptor agonist used to treat conditions such as plaque psoriasis and psoriasis. It is classified as an agonist in the drug class and works by activating the glucocorticoid receptor.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Halobetasol 0.05% ointment |
|---|---|
| Sponsor | Patel, Rita Vikram, M.D. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Randomized Study to Compare the Bioavailability of Two Halobetasol Propionate 0.05% Topical Ointments
- Ammonium Lactate Lotion 12% (Lac-hydrin®) and Halobetasol Propionate Ointment 0.05% (Ultravate®) in the Treatment and Maintenance of Psoriasis (PHASE4)
- Assessment for Tachyphylaxis to Topical Corticosteroids in the Treatment of Psoriasis (PHASE1)
- The Dose-response Study of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects (PHASE1)
- Pivotal Bioequivalence Study of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Halobetasol 0.05% ointment CI brief — competitive landscape report
- Halobetasol 0.05% ointment updates RSS · CI watch RSS
- Patel, Rita Vikram, M.D. portfolio CI
Frequently asked questions about Halobetasol 0.05% ointment
What is Halobetasol 0.05% ointment?
Who makes Halobetasol 0.05% ointment?
What development phase is Halobetasol 0.05% ointment in?
Related
- Manufacturer: Patel, Rita Vikram, M.D. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing