Approval Probability
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Adjusted LOA
ML Risk
High Dose Ha44 0.74% w/w · 1 trial · 1 indication
Clinically significant changes in Physical Examinations, vital signs, safety laboratory tests and assessments of scalp and eye irritation and Electrocardiogram. The frequency and severity of Adverse Events.
| Arm | Type | Description |
|---|---|---|
| Ha44 Gel 0.74% w/w | EXPERIMENTAL | Open label, one arm |
| Name | Type | Description |
|---|---|---|
| Ha44 Gel 0.74% w/w | DRUG | HA44 Gel 0.74% comprises of Abametapir as the active pharmaceutical ingredient and Benzyl Alcohol as one of the excipients. |
Inclusion Criteria: 1. Male or female, 6months \< 3years of age 2. Good health 3. Active head lice infestation defined as the presence of at least 3 live lice 4. Dermatological condition of scalp (at least G2 erythema or pruritus with evidence of excoriation/inflammation) 5. Parent/guardian agrees ...
High Dose Ha44 0.74% w/w is an investigational small molecule gel being developed by Dr. Reddy's Laboratories Ltd for the treatment of head lice infestation. It is applied topically and is in Phase 2 clinical development. It has not been approved by the FDA.
High Dose Ha44 0.74% w/w is being studied for the treatment of head lice infestation, a parasitic condition of the scalp. The development program has focused on pediatric use, with the completed Phase 2 trial enrolling children as young as 6 months of age.
High Dose Ha44 0.74% w/w is being developed by Dr. Reddy's Laboratories Ltd, which trades on the New York Stock Exchange under the ticker RDY. The company is the sponsor of the clinical program for this topical head lice treatment candidate.
High Dose Ha44 0.74% w/w is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The drug remains investigational and has not received FDA approval for head lice infestation.
High Dose Ha44 0.74% w/w has been evaluated in one completed Phase 2 trial, NCT02010333, titled A Pediatric Safety and Pharmacokinetics Study of Ha44 Gel Administered Topically for Treatment of Head Lice Infestation. The study enrolled 22 participants in the United States and included males and females aged 6 months and older.