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Ivermectin Lotion, 0.5%
Ivermectin Lotion, 0.5% is a Small molecule drug developed by Sun Pharmaceutical Industries, Inc.. It is currently in Phase 1 development. Also known as: ivermectin.
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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 | Ivermectin Lotion, 0.5% |
|---|---|
| Also known as | ivermectin |
| Sponsor | Sun Pharmaceutical Industries, Inc. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Clinical Endpoint Bioequivalence Study to Assess Efficacy and Safety of Ivermectin 0.5% Lotion in the Treatment of Head Lice (PHASE3)
- Clinical Endpoint Study of Ivermectin 0.5% Lotion (PHASE3)
- A Bioequivalence Study, Comparing Two Formulations of Ivermectin Lotion, 0.5% (PHASE1)
- Efficacy and Safety of Topical 0.5% Ivermectin Lotion for the Treatment of Head Lice Infestation in Filipinos (PHASE2)
- Ivermectin in the Treatment of Head Lice (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 Lotion, 0.5% CI brief — competitive landscape report
- Ivermectin Lotion, 0.5% updates RSS · CI watch RSS
- Sun Pharmaceutical Industries, Inc. portfolio CI
Frequently asked questions about Ivermectin Lotion, 0.5%
What is Ivermectin Lotion, 0.5%?
Who makes Ivermectin Lotion, 0.5%?
Is Ivermectin Lotion, 0.5% also known as anything else?
What development phase is Ivermectin Lotion, 0.5% in?
Related
- Manufacturer: Sun Pharmaceutical Industries, Inc. — full pipeline
- Also known as: ivermectin
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing