TheraRadar
Data updated: May 26, 2026

SKLICE (ivermectin)

Dermatology Approved 2012-02-07
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
14
Years on Market

Details

Status
Over-the-counter
First Approved
2012-02-07
Routes
TOPICAL
Dosage Forms
LOTION

Companies

ARBOR PHARMS LLC
Active Ingredient: IVERMECTIN

SKLICE Approval History

2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2012 to 2021 · 1 indication expansions
May 2021 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter Label
Oct 2020 SUPPL
Efficacy
FDA Letter Label
Jun 2017 SUPPL
Label · Labeling
FDA Letter Label

What SKLICE Treats

2 FDA approvals

Originally approved for its first indication in 2012 . Covers 2 distinct patient populations.

  • Other (2)
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Clinical Trial Registry

65 trials
Trial Sponsor ID Phase Status Title
NCT05318469 IIT2022-07-YUAN-IB-TNBC Ph 1, Ph 2 recruiting Ivermectin in Combination With Balstilimab or Pembrolizumab in Patients With Metastatic Triple Negative Breast Cancer
NCT04510194 results posted GIM-2020-29324 Ph 3 completed COVID-OUT: Early Outpatient Treatment for SARS-CoV-2 Infection (COVID-19)
NCT04275999 results posted IRB00062694 Ph 2 completed Rosacea and Ivermectin
NCT04311671 results posted MDGH-MOX-3002 Ph 3 completed Safety of a Single Dose of Moxidectin Compared With Ivermectin in Individuals Living in Onchocerciasis Endemic Areas and in Individuals Living in Onchocerciasis Endemic Areas With High Levels of Lymphatic Filariasis Co-endemicity Receiving Concomitant Albendazole
NCT05041907 PLATCOV VIR21001 Ph 2 recruiting Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV)
NCT04410406 results posted 202005076 Ph 3 completed Moxidectin for LF, Cote d'Ivoire (DOLF)
NCT03876262 MDGH-MOX-3001 Ph 3 active not recruiting Safety and Efficacy of Annual or Biannual Doses of Moxidectin or Ivermectin for Onchocerciasis
NCT07145736 EKAIO KirbyI Ph 4 recruiting Moxidectin Versus Ivermectin as Mass Drug Administration for the Control of Onchocerciasis and Other Neglected Tropical Diseases
NCT04885530 results posted Pro00107921 3U24TR001608-05W1 Ph 3 completed ACTIV-6: COVID-19 Study of Repurposed Medications
NCT03967054 RIMDAMAL II results posted 1691 U01AI138910 Ph 3 completed Repeat Ivermectin Mass Drug Administrations for MALaria Control II
NCT04056325 StrongMoxi results posted 3 Ph 2, Ph 3 completed Efficacy, Safety, and PK of Ascending Dosages of Moxidectin Versus Ivermectin Against Strongyloides Stercoralis
NCT03690453 MAL18006 Ph 4 completed Effect of Ivermectin Metabolites on Mosquito Survival
NCT03074435 REACT InstitutRD 15SANIN213 Ph 3 completed Insecticide Resistance Management in Burkina Faso and Côte D'Ivoire
NCT04482686 PRG-049 Ph 1 completed Trial of Combination Therapy to Treat COVID-19 Infection
NCT02735707 REMAP-CAP U1111-1189-1653 2015-002340-14, 602525 Ph 3 recruiting Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
NCT02407782 SCRATCH CHUBX 2011/16 Ph 3 completed Oral Ivermectin Versus Topical Permethrin to Treat Scabies in Children and Adults
NCT05180461 DNDi-EMO-04 UHAS-REC A.1 [1] 20-21 Ph 2 active not recruiting Emodepside Phase II Trial for Treatment of Onchocerciasis
NCT06259383 EC:55-141-14-1-3/sub1 Ph 3 completed Oral Ivermectin for Chikungunya Viral Infection
NCT03605758 TSSI results posted 2012-233 Ph 3 terminated Treatment of Strongyloides Infection
NCT05894538 results posted Pro00107921_D 3U24TR001608-05W1 Ph 3 completed ACTIV-6: COVID-19 Study of Repurposed Medications - Arm D (Ivermectin 600)
NCT05993143 IVER-303 Ph 3 terminated Ivermectin to Prevent SARS-CoV-2 (COVID-19) Hospitalisation in Subjects Over 50
NCT05736861 results posted Pro00107921_A 3U24TR001608-05W1 Ph 3 completed ACTIV-6: COVID-19 Study of Repurposed Medications - Arm A (Ivermectin 400)
NCT05643820 CMHAtd-ETH-21-Derm-22 Ph 1 completed Comparison of Oral Ivermectin and Permethrin 5% Lotion in Treatment of Pediculosis Capitis
NCT05231603 I-CPEP NMRR-21-1371-60569 Ph 3 terminated Ivermectin for Post Exposure Prophylaxis of Covid-19
NCT05085665 results posted 201909003(2) Ph 4 completed Loiasis Cross-reactive Antigenemia and Treatment-related Adverse Events
NCT04447235 TITAN NP 1677/20 Ph 2 terminated Early Treatment With Ivermectin and LosarTAN for Cancer Patients With COVID-19 Infection
NCT04891250 ZIT ZIT Ph 4 withdrawn The Zambia Ivermectin Trial for the Treatment and Prevention of COVID-19
NCT04374019 results posted MCC-20-COVID-01-PMC Ph 2 terminated Novel Agents for Treatment of High-risk COVID-19 Positive Patients
NCT04602507 ECA-COVID-CES Ph 2 terminated Ivermectin in Adults With Severe COVID-19.
NCT04632706 results posted mdc-TTG-CT-001 Ph 1 completed Exploratory Ph I Trial of the Active IMP in Healthy Volunteers in Relation to COVID-19
NCT05076253 171/64 Ph 1, Ph 2 completed Efficacy of Ivermectin in COVID-19
NCT04894721 IVERNEX-TUC 5077/410 CH 2020 Ph 2, Ph 3 completed Prophylaxis for COVID-19: Ivermectin in Close Contacts of COVID-19 Cases (IVERNEX-TUC)
NCT04635943 SAINT-PERU EC-CNTEI-014-2020 Ph 2 completed Randomized Phase IIA Clinical Trial to Evaluate the Efficacy of Ivermectin to Obtain Negative PCR Results in Patients With Early Phase COVID-19
NCT02795117 results posted PRG-NY-15-013 Ph 3 completed Comparative Safety and Efficacy of Two Treatments in the Treatment of Inflammatory Lesions of Rosacea
NCT04431466 IFORS IFORS Ph 2 terminated A Study to Compare the Efficacy and Safety of Different Doses of Ivermectin for COVID-19
NCT02806414 results posted UCSD 160765 Ph 1, Ph 2 completed Evaluation of the Inhibitory Effects of Topical Ivermectin on Markers of Rosacea Specific Inflammation.
NCT04403555 tanta covid treatment Ph 2, Ph 3 completed Ivermectin as a Novel Therapy in COVID-19 Treatment
NCT04529525 IVERCORCOVID19 IVERCORCOVID19MSPICC Ph 2, Ph 3 completed Ivermectin to Prevent Hospitalizations in COVID-19
NCT04438850 COVER cover_1 Ph 2 terminated COVidIVERmectin: Ivermectin for Treatment of Covid-19
NCT04407507 SILVERBULLET results posted SARS-COV-IverMX-01 Ph 2 completed Efficacy, Safety and Tolerability of Ivermectin in Subjects Infected With SARS-CoV-2 With or Without Symptoms
NCT04784481 IVER-Leve 5077-410-CH2020 Ph 1, Ph 2 completed Ivermectin Reproposing for Mild Stage COVID-19 Outpatients
NCT04351347 ivermecin covid Ph 2, Ph 3 recruiting The Efficacy of Ivermectin in Larger Doses in COVID-19 Treatment
NCT03432442 PKIDEN VIR17003 Ph 2 completed Pharmacokinetics and Pharmacodynamics of Ivermectin in Pediatric Dengue Patients
NCT04746365 IRICT 1029076 2101001 Ph 4 completed Ivermectin Role in Covid-19 Clinical Trial
NCT04739410 IRB#FMH-07-2020-IRB-766-M Ph 4 completed Effectiveness of Ivermectin in SARS-CoV-2/COVID-19 Patients
NCT04646109 results posted IVMC_03 Ph 3 completed Ivermectin for Severe COVID-19 Management
NCT04390022 SAINT results posted SAINT Ph 2 completed Sars-CoV-2/COVID-19 Ivermectin Navarra-ISGlobal Trial
NCT04391127 2020-A-09 Ph 3 completed Hydroxychloroquine and Ivermectin for the Treatment of COVID-19 Infection
NCT04041453 HI4T results posted 01-2019 Ph 2 completed Albendazole Plus High Dose Ivermectin for Trichuriasis in Pediatric Patients
NCT03852303 OAETREATe B300201733349 Ph 4 completed Ivermectin Treatment of Persons With Onchocerciasis-associated Epilepsy

Showing 50 of 65 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

SKLICE FDA Label Details

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Data Sources

FDA Approval: NDA202736 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.