MedPath

Moxidectin

Generic Name
Moxidectin
Drug Type
Small Molecule
Chemical Formula
C37H53NO8
CAS Number
113507-06-5
Unique Ingredient Identifier
NGU5H31YO9

Overview

Moxidectin is a potent, broad-spectrum endectocide (antiparasitic that is active against endo- and ecto-parasites) with activity against nematodes, insects, and acari. It was first used in cattle followed by an approved use in general animals. It is a semi-synthetic methoxine derivative of nemadectin which is a 16-member pentacyclic lactone of the milbemycin class. Moxidectin differs by the absence of a disaccharide moiety on carbon 13, a substituted olefinic side chain at carbon 25 and a unique methoxime moiety at carbon 23. Due to these modifications, moxidectin is classified as a second generation macrocyclic lactone. Moxidectin was developed by Medicines Development for Global Health and FDA approved in June 13, 2018.

Indication

Moxidectin is indicated for the treatment of river blindness, also called onchocerciasis, in patients aged 12 years and older. River blindness is caused by a parasitic worm Onchocerca volvulus and it is manifested as severe itching, disfiguring skin conditions and visual impairment caused by the worm's larvae. The transmission of Onchocerca volvulus is performed person to person by black flies that breed in fast-flowing rivers in sub-Saharan Africa, Yemen and South and Central America. The larvae released by the adult parasite invade skin and eyes where they can produce the severe disease manifestations.

Associated Conditions

  • Onchocerciasis caused by Infection with Onchocerca volvulus

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/01/27
Phase 4
Recruiting
Eye Research Foundation, Inc.
2024/01/03
Phase 3
Completed
Jennifer Keiser
2023/10/06
Phase 2
ENROLLING_BY_INVITATION
2023/05/25
Phase 2
Completed
2021/04/19
Phase 3
Completed
Jennifer Keiser
2021/01/27
Phase 3
Completed
Jennifer Keiser
2021/01/07
Phase 2
Completed
Jennifer Keiser
2020/06/01
Phase 3
Active, not recruiting
2020/03/17
Phase 3
Completed
2019/08/14
Phase 2
Completed
Jennifer Keiser

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Zoetis Inc.
54771-2684
ORAL
.12 mg in 1 1
5/23/2025
Zoetis Inc.
54771-2670
ORAL
.96 mg in 1 1
5/23/2025
Zoetis Inc.
54771-2667
ORAL
.06 mg in 1 1
5/23/2025
Zoetis Inc.
54771-2671
ORAL
1.44 mg in 1 1
5/23/2025
Zoetis Inc.
54771-2668
ORAL
.24 mg in 1 1
5/23/2025
Medicines Development for Global Health
71705-050
ORAL
2 mg in 1 1
11/30/2023
Zoetis Inc.
54771-2669
ORAL
.48 mg in 1 1
5/23/2025

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

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