CLINICAL TRIALS PROFILE FOR ELIMITE

All Clinical Trials for ELIMITE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02572986 ↗	A Study to Evaluate the Therapeutic Equivalence of Generic Permethrin Cream 5% to Elimite® in the Treatment of Scabies	Completed	Novum Pharmaceutical Research Services	Phase 3	2015-09-01	Scabies is an infestation of the skin by the human itch mite (Sarcoptes scabiei). Diagnosis of scabies is made based on clinical symptoms, such as nocturnal itching, and appearance and distribution of the rash. Definitive diagnosis includes the microscopic identification of the mite, mite eggs, or mite fecal matter in the skin. Topical permethrin is considered the drug of choice for the treatment of scabies. It is a synthetic pyrethroid that is safe for use in adults and children 2 months and older. This study will evaluate the therapeutic equivalence of a generic permethrin cream 5% to Elimite® in the Treatment of Scabies.
NCT02572986 ↗	A Study to Evaluate the Therapeutic Equivalence of Generic Permethrin Cream 5% to Elimite® in the Treatment of Scabies	Completed	Dr. Reddy's Laboratories Limited	Phase 3	2015-09-01	Scabies is an infestation of the skin by the human itch mite (Sarcoptes scabiei). Diagnosis of scabies is made based on clinical symptoms, such as nocturnal itching, and appearance and distribution of the rash. Definitive diagnosis includes the microscopic identification of the mite, mite eggs, or mite fecal matter in the skin. Topical permethrin is considered the drug of choice for the treatment of scabies. It is a synthetic pyrethroid that is safe for use in adults and children 2 months and older. This study will evaluate the therapeutic equivalence of a generic permethrin cream 5% to Elimite® in the Treatment of Scabies.
NCT02978508 ↗	Bio-equivalence Study Comparing Permethrin Cream, 5% With Elimite in Patients With Active Scabies.	Completed	bioRASI, LLC	Phase 3	2016-11-01	This is a multi-center, double-blind, randomized, two arm parallel design study. This study is comprised of two phases: screening and treatment. The screening period will be up to 5 days, followed by the treatment phase of 28±4 days. During the treatment phase subjects will be randomized to receive either test or reference treatments in a double-blind manner in an outpatient setting. Randomization of subjects will be in a 1:1 ratio for the test and reference drug arms and will be stratified by site. Screening will begin at visit 1, during which eligibility will be determined and prohibited treatments will be discontinued. Randomization will occur following the confirmation of the eligibility criteria at visit 2 (baseline, Day 1) i.e. initiation of treatment phase. The treatment phase will be 28±4 days in duration wherein subject will receive treatment with investigational product (either test or reference) on Day 1 or Baseline (visit 2). Safety and tolerability assessments will be performed on Day 7 (visit 3). Efficacy, safety and tolerability will be assessed on Day 14 (visit 4) followed by the End of study visit on Day 28 (visit 5). If positive identification of scabies is confirmed at Day 14 (visit 4), the subject will be retreated with the second application of the investigational product.
NCT02978508 ↗	Bio-equivalence Study Comparing Permethrin Cream, 5% With Elimite in Patients With Active Scabies.	Completed	Mayne Pharma International Pty Ltd	Phase 3	2016-11-01	This is a multi-center, double-blind, randomized, two arm parallel design study. This study is comprised of two phases: screening and treatment. The screening period will be up to 5 days, followed by the treatment phase of 28±4 days. During the treatment phase subjects will be randomized to receive either test or reference treatments in a double-blind manner in an outpatient setting. Randomization of subjects will be in a 1:1 ratio for the test and reference drug arms and will be stratified by site. Screening will begin at visit 1, during which eligibility will be determined and prohibited treatments will be discontinued. Randomization will occur following the confirmation of the eligibility criteria at visit 2 (baseline, Day 1) i.e. initiation of treatment phase. The treatment phase will be 28±4 days in duration wherein subject will receive treatment with investigational product (either test or reference) on Day 1 or Baseline (visit 2). Safety and tolerability assessments will be performed on Day 7 (visit 3). Efficacy, safety and tolerability will be assessed on Day 14 (visit 4) followed by the End of study visit on Day 28 (visit 5). If positive identification of scabies is confirmed at Day 14 (visit 4), the subject will be retreated with the second application of the investigational product.
NCT03178942 ↗	Multiple-Site Study to Evaluate the Therapeutic Equivalence of Permethrin Cream, 5% in the Treatment of Scabies	Completed	Novum Pharmaceutical Research Services	Phase 3	2017-06-01	Study to Evaluate the Therapeutic Equivalence of Permethrin Cream 5%in the Treatment of Scabies.
NCT03178942 ↗	Multiple-Site Study to Evaluate the Therapeutic Equivalence of Permethrin Cream, 5% in the Treatment of Scabies	Completed	Encube Ethicals Pvt. Ltd.	Phase 3	2017-06-01	Study to Evaluate the Therapeutic Equivalence of Permethrin Cream 5%in the Treatment of Scabies.

Clinical Trial Conditions for ELIMITE

Condition Name

Condition Name for ELIMITE
Intervention	Trials
Scabies	4

Condition MeSH

Condition MeSH for ELIMITE
Intervention	Trials
Scabies	4

Clinical Trial Locations for ELIMITE

Trials by Country

Trials by Country for ELIMITE
Location	Trials
United States	18
El Salvador	2
Puerto Rico	1
Panama	1

Trials by US State

Trials by US State for ELIMITE
Location	Trials
Florida	4
Texas	3
California	3
Washington	2
Pennsylvania	2

Clinical Trial Progress for ELIMITE

Clinical Trial Phase

Clinical Trial Phase for ELIMITE
Clinical Trial Phase	Trials
Phase 3	4

Clinical Trial Status

Clinical Trial Status for ELIMITE
Clinical Trial Phase	Trials
Completed	4

Clinical Trial Sponsors for ELIMITE

Sponsor Name

Sponsor Name for ELIMITE
Sponsor	Trials
bioRASI, LLC	4
Novum Pharmaceutical Research Services	2
Saptalis Pharmaceuticals LLC	1

Sponsor Type

Sponsor Type for ELIMITE
Sponsor	Trials
Industry	10
Other	1

Elimite (Permethrin 5%): Clinical Trial Update, Market Analysis, and Projection

Last updated: April 29, 2026

What is ELIMITE and what is its current clinical status?

ELIMITE is the brand name for permethrin 5% cream (often sold as a topical scabicide). The core clinical claims historically center on scabies and (depending on jurisdiction/product labeling) related ectoparasite indications. Because ELIMITE is an established, off-patent topical product in most markets, the “clinical trials update” today is primarily incremental and post-approval rather than new Phase 3 drug-development programs.

Practical read-across for drug development timelines: there is no credible public signal of new late-stage registrational trials for ELIMITE specifically. The modern evidence base is dominated by:

• older randomized comparisons and safety/efficacy studies that led to approval,
• post-marketing surveillance and formulation/label refinements, and
• guideline incorporation.

For business planning, this translates into low probability of meaningful label expansion via new pivotal trials unless a sponsor targets a new proprietary formulation, delivery system, or new indication with a narrow regulatory pathway.

Are there ongoing or recent ELIMITE-specific clinical trials?

No ELIMITE-specific, registrationally decisive Phase 2/3 programs are identifiable from public clinical trial reporting in the sense investors typically track for near-term value inflection (new dosing regimens with comparative endpoints, new patient populations, or head-to-head superiority trials that could expand labeling). Publicly available clinical trial records for permethrin are dominated by older studies and generic/scaled studies, not a brand-level pipeline for ELIMITE.

What do major guidelines say (signal for market demand and uptake)?

Clinical guideline adoption is a key demand driver for scabies therapeutics, and permethrin is consistently included as a first-line option in many guideline documents globally. This supports baseline demand even without ongoing brand-specific trials.

Evidence anchors used in current practice (label and guideline level)

Domain	What is consistently supported for permethrin (ELIMITE)	Value impact
Indication	Scabies treatment	Maintains steady usage across outbreaks and routine care
Use pattern	Topical application with repeat dosing per protocol	Limits payer friction; supports household-level prescribing
Safety	Known topical tolerability profile	Lowers barrier to adoption versus newer agents

What market structure drives ELIMITE revenue?

ELIMITE’s market behavior is typical for older topical dermatology products:

• pricing pressure from generics and private-label equivalents,
• low switching cost for prescribers and pharmacies,
• volume spikes during seasonal outbreaks (regional outbreaks create short-term demand surges),
• competition on formulation and supply reliability, not on brand differentiation.

Competitive set (relevant substitution risk)

Category	Examples (class-level)	Competitive implication for ELIMITE
Other topical scabicides	permethrin 1%/5% variants; sulfur topical products	Direct formulation substitution; drives price erosion
Oral options	ivermectin (where approved for scabies)	Shifts treatment preference in some markets, depending on access and labeling
Newer topical agents	limited by geography and adoption	Creates sporadic brand displacement risk, not structural collapse

How is the market evolving for scabies therapeutics?

Across global markets, scabies demand is stable with episodic increases. The structural drivers are:

• persistence of scabies as a public health issue,
• household and institutional outbreaks (schools, shelters, long-term care),
• ongoing reliance on topical therapies where oral access or approvals are limited.

ELIMITE’s business case is therefore dominated by distribution reach and pharmacy formularies, not pipeline breakthroughs.

What is the market size and how should ELIMITE be projected?

A complete, audit-ready projection requires region-specific unit sales, channel mix (retail vs institutional), and competitive price bands. Those inputs are not provided here as a dataset, so this projection is limited to a scenario framework tied to the market’s known structural forces: generics pressure, outbreak seasonality, and substitution with ivermectin where available.

Projection model (brand-level reality for ELIMITE)

Use three drivers:

1. Units: driven by scabies prevalence and outbreaks; generally stable with seasonal variability.
2. Net price: pressured by generics and rebate dynamics.
3. Share: stable for well-established brands but erodes versus lower-cost permethrin generics and alternative mechanisms in some geographies.

Base-case projection logic

• Units: flat to modest growth in typical markets due to recurring demand and institutional prescribing.
• Net price: slight decline to flat due to generic competition.
• Revenue: flat to low single-digit decline in mature markets; potentially stable where brand supply and contracting support maintain share.

Upside/downside bounds

Scenario	Unit trend	Price trend	Revenue direction
Base case	flat to +2% CAGR	-1% to 0% annually	flat to slight growth
Downside	-1% to -3% annually	-3% to -5% annually	mid single-digit decline
Upside	+2% to +4% annually	-1% annually	low to mid single-digit growth

What would move ELIMITE’s value in the next 3 to 5 years?

For an established topical scabicide, value movement comes from:

• contracting/formulary changes (tender cycles, pharmacy benefit manager decisions),
• availability (supply continuity, contract wins),
• regulatory/label actions that expand eligible patient populations or simplify regimens,
• competitive displacement from oral alternatives or cheaper topicals.

No evidence-based pipeline signal indicates ELIMITE is positioned for a major label expansion driven by new pivotal trials.

Clinical and regulatory profile (what matters for payer and access)

Core practical attributes

• Topical scabicide with a known safety profile.
• Standard-of-care positioning in many guideline pathways.
• Treatment regimens generally involve repeat dosing and household contact management, which affects prescribing workflow and reimbursement patterns.

Regulatory status

ELIMITE is an established product; as a brand, it faces generic competition in most markets where permethrin 5% exists as an approved equivalent.

Key takeaways

• ELIMITE is a mature, off-patent topical scabicide centered on scabies treatment with limited prospects for near-term registrational trial-driven value inflection.
• Clinical evidence and guideline adoption support stable baseline demand, but market outcomes are dominated by generic substitution, net pricing pressure, and competitive access rather than new clinical programs.
• A defensible projection frames ELIMITE revenue as flat to low single-digit decline in mature markets, with upside or downside tied primarily to formulary retention and share versus generics and oral alternatives.
• Near-term value levers are contracting, distribution continuity, and any regulatory simplification rather than new Phase 2/3 trial results.

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FAQs

1) Is ELIMITE likely to have new Phase 3 trials that change its label soon?
There is no credible public signal of brand-level, registrationally decisive Phase 2/3 ELIMITE trials.

2) What drives ELIMITE demand in practice?
Recurring scabies prevalence with periodic outbreaks and guideline-supported use for first-line treatment.

3) What is the biggest competitive threat to ELIMITE revenue?
Low-cost permethrin equivalents and, in some markets, substitution toward oral ivermectin where clinically and regulatory feasible.

4) How should investors treat “clinical trial updates” for older topical drugs like ELIMITE?
Expect incremental updates rather than pipeline-based label expansion; model value around market access and pricing rather than late-stage efficacy breakthroughs.

5) What is the most realistic revenue outlook range for ELIMITE?
Base case is typically flat to slight decline or modest growth in share-protected settings; downside depends on pricing compression and share loss.

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References

[1] FDA. (n.d.). OTC scabicides and permethrin-related regulatory information and labeling (search portal pages). U.S. Food and Drug Administration. https://www.fda.gov
[2] National Health Service (NHS). (n.d.). Scabies: treatment (permethrin guidance). NHS UK. https://www.nhs.uk
[3] Centers for Disease Control and Prevention (CDC). (n.d.). Scabies (treatment guidance including permethrin). CDC. https://www.cdc.gov
[4] European Medicines Agency (EMA). (n.d.). European public assessment and product information for permethrin-containing medicines (search portal). EMA. https://www.ema.europa.eu
[5] PubMed. (n.d.). Permethrin scabies clinical studies and reviews (literature index). National Library of Medicine. https://pubmed.ncbi.nlm.nih.gov