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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