TheraRadar
Data updated: May 26, 2026

SOOLANTRA (ivermectin)

Trial Activity: Declining 7 active trials
Dermatology Approved 2014-12-19

Soolantra is a topical cream that treats the inflammatory lesions associated with rosacea. It helps patients manage the visible bumps and blemishes that often occur with this skin condition. This medication is used to reduce the skin irritation and inflammation typically seen in rosacea patients.

Source: FDA Label • GALDERMA LABS LP • Antiparasitic
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How SOOLANTRA Works

While Soolantra is classified as an antiparasitic and pediculicide, the specific way it works to improve rosacea lesions is unknown. There is currently no established explanation for how the drug interacts with the skin to produce its therapeutic effects.

Source: FDA Label

Development Insights

Medicines Development for Global Health conducting 3 trials (5%)
46 indications explored (Broad Platform)
→ covid19 (13 trials)
→ covid-19 (8 trials)
→ onchocerciasis (7 trials)
1
Indication
--
Phase 3 Trials
11
Years on Market

Details

Status
Prescription
First Approved
2014-12-19
Patent Cliff
2034

Pro Metrics

Patent cliff and revenue data

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Routes
TOPICAL
Dosage Forms
CREAM

Companies

GALDERMA LABS LP
Active Ingredient: IVERMECTIN

SOOLANTRA Approval History

2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2014 to 2022
Oct 2022 SUPPL
Label · Labeling
FDA Letter Label
Apr 2018 SUPPL
Label · Labeling
FDA Letter Label
Dec 2014 ORIGINAL
New Form · Type 3 - New Dosage Form
FDA Letter Label

What SOOLANTRA Treats

1 indications

SOOLANTRA is approved for 1 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Rosacea
Source: FDA Label

SOOLANTRA Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

EPSOLAY
MAYNE PHARMA
2022 1 indic.
ZILXI
JOURNEY
2020 1 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to SOOLANTRA

3 of 12

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

CLOBEX
CLOBETASOL PROPIONATE
1 shared
GALDERMA LABS LP
Shared indications:
Rosacea
EMROSI
MINOCYCLINE HYDROCHLORIDE
1 shared
JOURNEY
Shared indications:
Rosacea
EPSOLAY
BENZOYL PEROXIDE
1 shared
MAYNE PHARMA
Shared indications:
Rosacea
View all 12 similar drugs Pro
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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.

SOOLANTRA FDA Label Details

Indications & Usage

FDA Label (PDF)

SOOLANTRA is indicated for the treatment of Rosacea.

View full patent landscape →
5 OB patents · 2 families · 72 international docs across 17 countries

SOOLANTRA Patents & Exclusivity

Latest Patent: Mar 2034

Patents (5 active)

US9233118 Expires Mar 13, 2034
US9089587 Expires Mar 13, 2034
US9233117 Expires Mar 13, 2034
US9782425 Expires Mar 13, 2034
US10206939 Expires Mar 13, 2034
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for SOOLANTRA

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2034
  • • 5 active patents

Trial Analysis

  • • 66 total trials
  • • Stage: Declining

Competitive Landscape

  • • 12 similar drugs
  • • Same target/indication analysis
Unlock Full Intelligence

Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA206255 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment