MedPath

Abametapir

Generic Name
Abametapir
Brand Names
Xeglyze
Drug Type
Small Molecule
Chemical Formula
C12H12N2
CAS Number
1762-34-1
Unique Ingredient Identifier
6UO390AMFB
Background

Abametapir is a novel pediculicidal metalloproteinase inhibitor used to treat infestations of head lice. The life cycle of head lice (Pediculus capitis) is approximately 30 days, seven to twelve of which are spent as eggs laid on hair shafts near the scalp. Topical pediculicides generally lack adequate ovicidal activity, including standard-of-care treatments such as permethrin, and many require a second administration 7-10 days following the first to kill newly hatched lice that resisted the initial treatment. The necessity for follow-up treatment may lead to challenges with patient adherence, and resistance to agents like permethrin and pyrethrins/piperonyl butoxide may be significant in some areas.

Investigations into novel ovicidal treatments revealed that several metalloproteinase enzymes were critical to the egg hatching and survival of head lice, and these enzymes were therefore identified as a potential therapeutic target. Abemetapir is an inhibitor of these metalloproteinase enzymes, and the first topical pediculicide to take advantage of this novel target. The improved ovicidal activity (90-100% in vitro) of abemetapir allows for a single administration, in contrast to many other topical treatments, and its novel and relatively non-specific mechanism may help to curb the development of resistance to this agent.

Abametapir was first approved for use in the United States under the brand name Xeglyze on July 27, 2020.

Indication

Abametapir is indicated, in the context of an overall lice management program, for the topical treatment of head lice infestation in patients 6 months of age and older.

Associated Conditions
Head Lice Infestation

Ovicidal Efficacy and Safety of Abametapir Lotion 0.74% Administered for the Treatment of Head Lice Infestation

Phase 2
Completed
Conditions
Head Lice Infestation
Interventions
First Posted Date
2014-03-27
Last Posted Date
2021-05-11
Lead Sponsor
Dr. Reddy's Laboratories Limited
Target Recruit Count
50
Registration Number
NCT02097485
Locations
🇦🇺

National Head Lice Treatment Centre, Ringwood East, Victoria, Australia

Dermal Safety Study to Evaluate the Sensitizing Potential of Abametapir Lotion

Phase 1
Completed
Conditions
Head Lice
Interventions
Other: Vehicle Lotion
Other: 0.1% sodium lauryl sulfate
Other: saline 0.9%
First Posted Date
2014-02-13
Last Posted Date
2020-04-29
Lead Sponsor
Dr. Reddy's Laboratories Limited
Target Recruit Count
238
Registration Number
NCT02062073
Locations
🇺🇸

TKL Reserach, Paramus, New Jersey, United States

Dermal Safety Study to Evaluate Potential Irritation of Abametapir Lotion

Phase 1
Completed
Conditions
Head Lice
Interventions
First Posted Date
2014-02-13
Last Posted Date
2021-07-26
Lead Sponsor
Dr. Reddy's Laboratories Limited
Target Recruit Count
40
Registration Number
NCT02061813
Locations
🇺🇸

TKL Reserach Inc, Paramus, New Jersey, United States

Study of the Efficacy and Safety of Abametapir Lotion Administered for the Treatment of Head Lice Infestation

Phase 3
Completed
Conditions
Head Lice Infestation
Interventions
First Posted Date
2014-02-13
Last Posted Date
2020-05-12
Lead Sponsor
Dr. Reddy's Laboratories Limited
Target Recruit Count
325
Registration Number
NCT02062060
Locations
🇺🇸

LSRN Research, Nashville, Tennessee, United States

🇺🇸

Wee Care Pediatrics, Layton, Utah, United States

🇺🇸

Haywood Pediatric, Clyde, North Carolina, United States

and more 4 locations

A Study of the Efficacy and Safety of Abametapir Lotion Administered for the Treatment of Head Lice Infestation

Phase 3
Completed
Conditions
Head Lice Infestation
Interventions
First Posted Date
2014-02-12
Last Posted Date
2020-09-23
Lead Sponsor
Dr. Reddy's Laboratories Limited
Target Recruit Count
379
Registration Number
NCT02060903
Locations
🇺🇸

Radiant reserach Inc., San Antonio, Texas, United States

🇺🇸

LSRN Reserach, West Palm Beach, Florida, United States

🇺🇸

Axis Clinical Trials, Los Angeles, California, United States

and more 4 locations

Safety and PK Study of Ha44 Gel Under Maximal Use Conditions for Treatment of Head Lice Infestation

Phase 2
Completed
Conditions
Head Lice Infestation
Interventions
First Posted Date
2013-07-25
Last Posted Date
2020-04-28
Lead Sponsor
Dr. Reddy's Laboratories Limited
Target Recruit Count
38
Registration Number
NCT01907490

Study to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in Healthy Volunteers

Phase 1
Completed
Conditions
Pediculosis
Interventions
First Posted Date
2012-01-26
Last Posted Date
2021-07-09
Lead Sponsor
Dr. Reddy's Laboratories Limited
Target Recruit Count
57
Registration Number
NCT01518699
Locations
🇺🇸

Spaulding Clinical, West Bend, Wisconsin, United States

© Copyright 2025. All Rights Reserved by MedPath