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Ultravate Cream
Ultravate Cream is a Small molecule drug developed by Bausch Health Americas, Inc.. It is currently in Phase 2 development. Also known as: Ultravate.
Ultravate Cream is a topical cream used to treat conditions such as psoriasis, including plaque psoriasis and psoriasis vulgaris, as well as hemorrhoids. The exact mechanism of action of Ultravate Cream is not specified in the provided information, but it is a vehicle cream, suggesting it may be a base or carrier for an active ingredient.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Ultravate Cream |
|---|---|
| Also known as | Ultravate |
| Sponsor | Bausch Health Americas, Inc. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Investigator Initiated Trial to Study Duobrii® Lotion in the Treatment of Mild Plaque Psoriasis in Adults (PHASE3)
- Anti-Inflammatory Effects of 0.045% Tazarotene/0.01% Halobetasol Lotion in Psoriasis (PHASE4)
- Safety and Efficacy of CITI-002 in Adult Patients With Moderate Grade Hemorrhoids (PHASE2)
- Randomized Study to Compare the Bioavailability of Three Halobetasol Propionate 0.05% Topical Creams
- Safety and Efficacy of IDP-122 Lotion When Applied Topically to Subjects With Moderate to Severe Plaque Psoriasis (PHASE2)
- Safety and Efficacy of IDP-118 Lotion to Ultravate® in the Treatment of Plaque Psoriasis (PHASE2)
- Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects With Moderate to Severe Plaque Psoriasis (PHASE1)
- Blinded Study of Topical Investigational Lotion Vs. Approved Cream in Treatment of Plaque Psoriasis (PHASE2)
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:
- Ultravate Cream CI brief — competitive landscape report
- Ultravate Cream updates RSS · CI watch RSS
- Bausch Health Americas, Inc. portfolio CI
Frequently asked questions about Ultravate Cream
What is Ultravate Cream?
Who makes Ultravate Cream?
Is Ultravate Cream also known as anything else?
What development phase is Ultravate Cream in?
Related
- Manufacturer: Bausch Health Americas, Inc. — full pipeline
- Also known as: Ultravate
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing