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ivermectin cream 0.5%
ivermectin cream 0.5% is a anthelmintic Small molecule drug developed by Rabin Medical Center. It is currently in Phase 3 development for Treatment of papulopustular rosacea.
Ivermectin cream 0.5% works by killing Demodex mites and other microfilariae that cause rosacea.
Ivermectin cream 0.5% works by killing Demodex mites and other microfilariae that cause rosacea. Used for Treatment of papulopustular 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 | ivermectin cream 0.5% |
|---|---|
| Sponsor | Rabin Medical Center |
| Drug class | anthelmintic |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 3 |
Mechanism of action
Ivermectin is a macrocyclic lactone that acts as an agonist of glutamate-gated chloride channels in invertebrates, leading to paralysis and death of the parasites. In humans, it is poorly absorbed through the skin, allowing it to target the parasites locally without systemic side effects.
Approved indications
- Treatment of papulopustular rosacea
Common side effects
- Pruritus
- Skin irritation
- Eye irritation
Key clinical trials
- Impact of Community Scabies Treatment on Head Lice Prevalence in the Solomon Islands (PHASE3)
- Topical 0.5% Ivermectin Cream for Treatment of Demodicidosis (PHASE3)
- A Pharmacokinetics (PK) Study in Lice Infested Children 6 Months to 3 Years of Age (PHASE1)
- A Study Comparing the Safety and Efficacy of 0.5% Ivermectin Cream to Placebo in Lice Infested Subjects (PHASE3)
- Study Comparing the Safety and Efficacy of 0.5% Ivermectin Cream to Placebo in Lice Infested Subjects (PHASE2)
- A Safety and Efficacy Study Comparing 0.5% Ivermectin Cream to a Vehicle Control in Subjects With Head Lice Infestation (PHASE3)
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:
- ivermectin cream 0.5% CI brief — competitive landscape report
- ivermectin cream 0.5% updates RSS · CI watch RSS
- Rabin Medical Center portfolio CI
Frequently asked questions about ivermectin cream 0.5%
What is ivermectin cream 0.5%?
How does ivermectin cream 0.5% work?
What is ivermectin cream 0.5% used for?
Who makes ivermectin cream 0.5%?
What drug class is ivermectin cream 0.5% in?
What development phase is ivermectin cream 0.5% in?
What are the side effects of ivermectin cream 0.5%?
Related
- Drug class: All anthelmintic drugs
- Manufacturer: Rabin Medical Center — full pipeline
- Therapeutic area: All drugs in Dermatology
- Indication: Drugs for Treatment of papulopustular rosacea
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing