MedPath

Ivermectin

Generic Name
Ivermectin
Brand Names
Sklice, Soolantra, Stromectol
Drug Type
Small Molecule
Chemical Formula
C95H146O28
CAS Number
70288-86-7
Unique Ingredient Identifier
8883YP2R6D

Overview

Ivermectin is a semi-synthetic antiparasitic medication derived from avermectins, a class of highly-active broad-spectrum antiparasitic agents isolated from the fermentation products of Streptomyces avermitilis. Ivermectin itself is a mixture of two avermectins, comprising roughly 90% 5-O-demethyl-22,23-dihydroavermectin A (22,23-dihydroavermectin B) and 10% 5-O-demethyl-25-de(1-methylpropyl)-22,23-dihydro­-25-(1-methylethyl)avermectin A (22,23-dihydroavermectin B). Ivermectin is mainly used in humans in the treatment of onchocerciasis, but may also be effective against other worm infestations (such as strongyloidiasis, ascariasis, trichuriasis and enterobiasis). Applied topically, it may be used in the treatment of head lice infestation. With the advent of 2020 and the COVID-19 pandemic, ivermectin began garnering notoriety due to its off-label use for the prophylaxis and treatment of COVID-19. While studies are still ongoing, much of the evidence for ivermectin in COVID-19 relies on pre-print in vitro data, and the clinical utility of this data remains unclear. Due to a number of factors - for example, the relatively low number of patients per trial and the speed at which these trials were conducted - studies on the use of ivermectin in COVID-19 have been fraught with statistical errors and accusations of plagiarism. In addition, the use of aggregate patient data in large-scale meta-analyses (as opposed to individual patient data (IPD)) has been shown to disguise otherwise blatant data errors, such as extreme terminal digit bias and the duplication of blocks of patient records. Until high-quality, peer-reviewed data regarding both the safety and efficacy of ivermectin for COVID-19 in humans becomes available, the use of ivermectin for these purposes should be avoided in favour of thoroughly-vetted therapies (e.g. COVID-19 vaccines like Comirnaty).

Indication

Administered topically, ivermectin cream is indicated for the treatment of inflammatory lesions associated with rosacea. An over-the-counter ivermection lotion is commercially available and indicated for the topical treatment of head lice infestations in patients ≥6 months of age. Orally administered ivermectin is indicated as a broad-spectrum anti-parasitic for the treatment of intestinal strongyloidiasis caused by Strongyloides stercoralis and onchocerciasis caused by Onchocerca volvulus. Systemic ivermectin therapy is used internationally for the treatment of various tropical diseases, including filariasis, cutaneous larva migrans, and Loa loa infection, amongst others.

Associated Conditions

  • Ascariasis
  • Demodex Infestation
  • Enterobiasis
  • Filariasis caused by Loa Loa
  • Gnathostomiasis
  • Head Lice Infestation
  • Malaria
  • Myiasis
  • Onchocerciasis caused by Infection with Onchocerca volvulus
  • Rosacea
  • Scabies
  • Strongyloidiasis caused by Strongyloides Stercoralis Infection
  • Trichuriasis

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/03/26
Phase 2
Not yet recruiting
Children Hospital and Institute of Child Health, Lahore
2024/08/16
Phase 1
Completed
Humanis Saglık Anonim Sirketi
2024/07/11
N/A
Completed
Jennifer Keiser
2024/03/27
Phase 4
Active, not recruiting
Phramongkutklao College of Medicine and Hospital
2024/02/20
Not Applicable
Not yet recruiting
2024/02/14
Phase 3
Completed
2024/02/09
Early Phase 1
Recruiting
2023/12/28
Phase 2
Completed
Jennifer Keiser
2023/10/06
Phase 2
ENROLLING_BY_INVITATION
2023/09/13
Phase 2
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Merck Sharp & Dohme LLC
0006-0032
ORAL
3 mg in 1 1
5/11/2022
Central Texas Community Health Centers
76413-155
ORAL
3 mg in 1 1
3/9/2017
Huvepharms, Inc
23243-4680
SUBCUTANEOUS
10 mg in 1 mL
4/28/2025
Department of State Health Services, Pharmacy Branch
55695-019
ORAL
3 mg in 1 1
3/11/2016
Zydus Lifesciences Limited
70771-1728
TOPICAL
10 mg in 1 g
6/7/2023
Mayne Pharma Inc.
68308-701
TOPICAL
10 mg in 1 g
11/21/2023
Padagis Israel Pharmaceuticals Ltd
45802-102
TOPICAL
10 mg in 1 g
10/31/2022
NuCare Pharmaceuticals,Inc.
68071-2242
ORAL
3 mg in 1 1
1/20/2022
Padagis US LLC
0574-2107
TOPICAL
10 mg in 1 g
2/21/2023
Bryant Ranch Prepack
63629-8754
TOPICAL
10 mg in 1 g
8/25/2021

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
SOOLANTRA CREAM 10MG/G
SIN15197P
CREAM
10 mg/g
3/23/2017

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Ivermectin Capsules
国药准字H20041733
化学药品
胶囊剂
6/3/2020
Ivermectin Chewable Tablets
国药准字H20041990
化学药品
片剂
6/3/2020
Ivermectin Tablets
国药准字H20010758
化学药品
片剂
6/3/2020

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
SOOLANTRA ivermectin 10 mg/g cream tube
227125
Medicine
A
9/14/2015
VASTREKA ivermectin 10 mg/g cream tube
227242
Medicine
A
9/14/2015
STROMECTOL ivermectin 3mg tablet blister pack
181338
Medicine
A
5/13/2011

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