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Rhofade Cream, 1%
Rhofade Cream, 1% is a Alpha-1 adrenergic agonist Small molecule drug developed by Actavis Inc.. It is currently in Phase 3 development for Persistent facial erythema associated with rosacea. Also known as: Oxymetazoline hydrochloride.
Oxymetazoline is an alpha-1 adrenergic agonist that constricts blood vessels in the skin to reduce facial redness and flushing.
Rhofade Cream is a topical cream containing oxymetazoline hydrochloride 1% used to treat conditions such as rosacea and erythema. It is specifically designed to reduce erythema associated with rosacea.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Rhofade Cream, 1% |
|---|---|
| Also known as | Oxymetazoline hydrochloride |
| Sponsor | Actavis Inc. |
| Drug class | Alpha-1 adrenergic agonist |
| Target | Alpha-1 adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 3 |
Mechanism of action
Oxymetazoline works by binding to alpha-1 adrenergic receptors on vascular smooth muscle cells, causing vasoconstriction of small blood vessels in the dermis. This reduces blood flow to the affected areas and decreases the visible erythema and flushing associated with rosacea. The effect is topical and localized to the area of application.
Approved indications
- Persistent facial erythema associated with rosacea
Common side effects
- Skin irritation or burning at application site
- Erythema rebound (worsening redness upon discontinuation)
- Pruritus
Key clinical trials
- Pulsed Dye Laser Treatment and Oxymetazoline Hydrochloride (HCL) 1% Cream for Erythematotelangiectatic Rosacea (PHASE4)
- A Study Comparing Oxymetazoline 1% Cream to RHOFADE (PHASE1)
- An Evaluation of the Reduction in Erythema in Adult Patients With Moderate to Severe Persistent Facial Erythema Associated With Rosacea (PHASE3)
- A Clinical Endpoint Bioequivalence Study of "Oxymetazoline Hydrochloride Cream" (PHASE3)
- Safety and Tolerability of Oxymetazoline and Energy-Based Therapy in Participants With Rosacea (PHASE4)
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:
- Rhofade Cream, 1% CI brief — competitive landscape report
- Rhofade Cream, 1% updates RSS · CI watch RSS
- Actavis Inc. portfolio CI
Frequently asked questions about Rhofade Cream, 1%
What is Rhofade Cream, 1%?
How does Rhofade Cream, 1% work?
What is Rhofade Cream, 1% used for?
Who makes Rhofade Cream, 1%?
Is Rhofade Cream, 1% also known as anything else?
What drug class is Rhofade Cream, 1% in?
What development phase is Rhofade Cream, 1% in?
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What does Rhofade Cream, 1% target?
Related
- Drug class: All Alpha-1 adrenergic agonist drugs
- Target: All drugs targeting Alpha-1 adrenergic receptor
- Manufacturer: Actavis Inc. — full pipeline
- Therapeutic area: All drugs in Dermatology
- Indication: Drugs for Persistent facial erythema associated with rosacea
- Also known as: Oxymetazoline hydrochloride
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing