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Ivermectin Cream, 1%
Ivermectin Cream, 1% is a Antiparasitic agent Small molecule drug developed by Actavis Inc.. It is currently in Phase 3 development for Rosacea (inflammatory lesions), Scabies.
Ivermectin binds to glutamate-gated chloride channels in parasites and arthropods, causing paralysis and death of the organisms.
Ivermectin binds to glutamate-gated chloride channels in parasites and arthropods, causing paralysis and death of the organisms. Used for Rosacea (inflammatory lesions), Scabies.
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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, 1% |
|---|---|
| Sponsor | Actavis Inc. |
| Drug class | Antiparasitic agent |
| Target | Glutamate-gated chloride channels (invertebrate-specific) |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 3 |
Mechanism of action
Ivermectin is a macrocyclic lactone that selectively activates chloride channels in invertebrate nervous and muscular systems, leading to hyperpolarization and paralysis. When applied topically as a 1% cream, it penetrates the skin to target parasitic mites and other arthropods responsible for conditions like rosacea and scabies. The drug has high selectivity for invertebrate channels over mammalian GABA receptors, making it relatively safe for topical use.
Approved indications
- Rosacea (inflammatory lesions)
- Scabies
Common side effects
- Skin irritation or burning at application site
- Erythema
- Pruritus
- Dryness
Key clinical trials
- Ivermectin Safety in Small Children (PHASE2)
- Comparison of Permethrin and Ivermectin in Children Greater Than 6 Yrs Age for Treatment of Scabies (PHASE2)
- Potassium-titanyl Phosphate (KTP) Laser vs KTP Laser and Ivermectin Cream for Facial Rosacea (PHASE2)
- Bioequivalence Study of Ivermectin 1% Cream and Soolantra (Ivermectin) 10 mg/g Cream (PHASE1)
- Ivermectin/ Permethrin for Scabies (PHASE4)
- Comparative Study Between Topical Permethrin 5% and Oral Ivermectin for the Treatment of Scabies (PHASE1)
- Treatment of Ocular Demodex Infestation With Topical Ivermectin Cream 1% (PHASE1)
- Oracea Soolantra Association in Participants With Severe 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:
- Ivermectin Cream, 1% CI brief — competitive landscape report
- Ivermectin Cream, 1% updates RSS · CI watch RSS
- Actavis Inc. portfolio CI
Frequently asked questions about Ivermectin Cream, 1%
What is Ivermectin Cream, 1%?
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Who makes Ivermectin Cream, 1%?
What drug class is Ivermectin Cream, 1% in?
What development phase is Ivermectin Cream, 1% in?
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What does Ivermectin Cream, 1% target?
Related
- Drug class: All Antiparasitic agent drugs
- Target: All drugs targeting Glutamate-gated chloride channels (invertebrate-specific)
- Manufacturer: Actavis Inc. — full pipeline
- Therapeutic area: All drugs in Dermatology
- Indication: Drugs for Rosacea (inflammatory lesions)
- Indication: Drugs for Scabies
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing