Ivermectin Clinical Trials: What Is Registered, What Has Reported, and What That Means

A search of ClinicalTrials.gov returns a long list of ivermectin studies, covering parasitic infections, skin conditions, mosquito-borne disease transmission and COVID-19. A listing on that register means a sponsor filed a record describing a study. It does not mean the study was completed, that it worked, or that the US Food and Drug Administration is reviewing the drug for that use. As of 28 September 2026, the FDA-approved oral label remains narrow: the STROMECTOL prescribing information (Merck Sharp & Dohme, revised 09/2024, on DailyMed) lists two indications only — intestinal (nondisseminated) strongyloidiasis due to Strongyloides stercoralis and onchocerciasis due to Onchocerca volvulus. You can see the approved indications set out in full separately.

This page explains what a registry record contains, how to tell a registered study from a reported one, where posted results actually live, and what the FDA, NIH and CDC have said in their own documents. It deliberately does not publish a running count of ivermectin trials, because that number changes daily and cannot be pinned to a dated primary source; instead, the last section shows you how to pull the current count yourself.

Key takeaways

Registration on ClinicalTrials.gov is an administrative filing by the sponsor. It is not a review, an endorsement or evidence of benefit.
A record's "Condition" field is what the sponsor chose to study — not an FDA-approved indication. FDA approval for human ivermectin tablets covers two parasitic infections, per the DailyMed label revised 09/2024.
Summary results posted on the register are unreviewed sponsor-submitted data; a peer-reviewed journal report and a preprint are two further, different things.
FDA's consumer page on ivermectin and COVID-19, content current as of 05 April 2024, states the agency has not authorized or approved ivermectin for preventing or treating COVID-19 in humans or animals.
Products labeled for animals are approved for animal use only and are not approved for use in people, in trials or outside them.

What ClinicalTrials.gov is, and what a registration does and does not mean

Hands and reading glasses over out-of-focus printed pages on a kitchen table, illustrating how to read a clinical trial registry record

ClinicalTrials.gov is a public register of clinical studies maintained by the National Library of Medicine, part of the National Institutes of Health. Records are submitted by the study's sponsor or principal investigator — the "responsible party" — and the register's own materials describe the information as supplied by that party rather than verified for scientific merit by NLM.

Registration is partly a legal obligation. ClinicalTrials.gov's reporting-requirements page explains that Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) requires responsible parties to register certain trials — "applicable clinical trials" — and to submit summary results, and that the HHS final rule implementing and expanding those duties took effect in January 2017. Many registered studies fall outside that definition entirely: investigator-initiated studies abroad, observational studies, and small trials of already-approved drugs may be registered voluntarily, often because journals require registration before they will consider a manuscript.

So a registration tells you that someone intended to run a study and described it in advance. That is genuinely useful — it creates a public, timestamped record of what was planned — but it is the beginning of the evidence trail, not the end of it.

How to read a trial record: phase, status, sponsor, primary outcome

People waiting on a wooden bench at a rural community health post where antiparasitic treatment programs are run

Four fields carry most of the weight.

Phase

Phase describes the stage of drug development, from early safety and dose-finding through to larger efficacy studies. For a drug already approved for other uses, sponsors frequently register Phase 2 or Phase 3 studies, and phase alone says nothing about size or quality.

Recruitment status

ClinicalTrials.gov's "How to Read a Study Record" page defines the statuses plainly: suspended means the study stopped early but may restart; terminated means it stopped early and will not restart; completed means it ended normally. The register's protocol data element definitions add that withdrawn means the study was halted before the first participant was enrolled.

Sponsor and responsible party

The sponsor may be a federal agency, a university, a hospital, a company or an individual physician. A federally funded platform trial and a single-site study run by one clinician both appear as registry records with the same visual weight.

Primary outcome measure

This is the pre-specified result the study was designed to detect, with its time frame. It is the single most informative field, because comparing the registered primary outcome against what was later reported is how readers detect outcome switching.

Registry field	What it tells you	What it does not tell you
Condition	What the sponsor set out to study	Anything about approved indications
Phase	Development stage as declared	Sample size, rigor or funding
Status	Whether the study is running, stopped or finished	Whether any data were analyzed or published
Primary outcome	The pre-specified endpoint and timing	The result
Results posted	That summary data were submitted	That the data were peer reviewed

Registered ivermectin trials by indication, as of the verification date

An emptied clinical trial site room with stacked chairs and an unused infusion stand, illustrating withdrawn and terminated study records

As of 28 September 2026, ivermectin records on the register cluster into recognizable groups. Two of them match the FDA-approved oral label: strongyloidiasis and onchocerciasis. Others do not — scabies, head lice, rosacea, lymphatic filariasis and mass drug administration programs, mosquito-borne disease transmission, and a large COVID-19 cohort registered mostly in 2020 and 2021.

Two distinctions matter when reading that list. First, the FDA-approved dermatologic products are separate approvals with their own indications: SOOLANTRA cream 1% (Galderma, NDA 206255) is indicated for inflammatory lesions of rosacea, and ivermectin lotion 0.5% is an over-the-counter head lice treatment whose Drug Facts panel gives the Purpose as "Lice treatment". Second, no FDA-approved human ivermectin product in the United States carries an approved indication for scabies, even though scabies studies are registered. A registry entry is a research question, not a label claim — the same gap that separates the drug's how the drug works pharmacology from what regulators have actually cleared it to treat.

Which have posted results, and where those results live

A man at a public library computer terminal looking up drug trial information in warm lamplight

A completed ivermectin study can leave its results in up to three different places, and they are not interchangeable.

The register's own results section. Records that have submitted summary data show a Study Results tab with participant flow, baseline characteristics, outcome measures and adverse events. Under FDAAA 801, results for applicable clinical trials are generally due within 12 months of the completion date, with limited provisions for delay.
A peer-reviewed journal article. Most published trials list their NCT number in the abstract or methods, which lets you match the paper back to its registration.
Nowhere. A substantial share of registry records, for ivermectin as for other drugs, are marked completed and never post results or publish.

The most frequently asked-about US government study is ACTIV-6, the NIH-supported decentralized outpatient platform trial of repurposed medicines for COVID-19 (NCT04885530), coordinated by the Duke Clinical Research Institute through PCORnet. The ACTIV-6 team's own 2023 description of the platform records that the trial enrolled more than 7,500 participants and had reported on ivermectin at two doses, alongside fluticasone and fluvoxamine. That is one trial among many, but it is the one people mean when they ask about an "ivermectin NIH trial".

Withdrawn, terminated and suspended records, and the reasons given

Ivermectin's COVID-19 cohort includes a visible number of records that never produced data. The register handles these three ways, using the definitions above: withdrawn before anyone enrolled, terminated after stopping for good, suspended with a possible restart.

Where a study stopped early, ClinicalTrials.gov's data element definitions provide a "Why Study Stopped" field — a brief explanation of the reason. The reasons sponsors typed into that field during 2020 to 2022 were commonly slow enrollment, expiry of funding, changes in standard of care that made the comparison obsolete, or institutional and regulatory decisions. Two cautions: the text is free-form and supplied by the sponsor, not audited; and many records simply go stale, last updated years ago with no explanation at all. An abandoned record is not a suppressed finding, and it is not a finding of any kind.

Why a registered trial is not evidence, and why a completed one may still not be

Registration proves planning. Completion proves the study ran. Neither proves the result is reliable. A completed trial can still be too small to detect a difference, can use a surrogate endpoint such as a laboratory measure rather than a clinical one, can be unblinded, or can report an outcome different from the one it registered.

Ivermectin's COVID-19 literature contains a well-documented instance of this going wrong. A 2022 analysis in Open Forum Infectious Diseases records that a study by Elgazzar and colleagues was retracted from the preprint server Research Square on 15 July 2021 over ethical concerns, with reported duplication in the participant data, and describes how excluding studies with concerns about bias changed the pooled survival estimate to a non-significant result. Several meta-analyses that had incorporated the preprint issued corrections. This is the ordinary reason to be careful with pooled numbers on a contested drug, and the same caution applies to comparisons between antiparasitic agents — see what the research does and does not show on that question, and the separate discussion of organisms with no label claim.

The difference between a peer-reviewed report, a preprint and a registry entry

Document	Who checked it	Can it be removed or corrected?
Registry entry	Sponsor submits; register checks completeness, not merit	Updated by the sponsor; history of changes is retained
Posted summary results	Sponsor submits; quality-control review for format and completeness	Corrected by the sponsor
Preprint	No peer review before posting	Yes — can be withdrawn or removed by the server, as Research Square did in July 2021
Peer-reviewed article	Editors and external reviewers	Yes — correction, expression of concern or retraction

None of these four is automatically trustworthy and none is automatically worthless. The useful habit is to check which one you are looking at before deciding how much weight it carries.

Where the FDA, NIH and CDC positions currently stand, with links to the source pages

FDA. The agency's consumer update "Ivermectin and COVID-19", content current as of 05 April 2024, states: "The FDA has not authorized or approved ivermectin for use in preventing or treating COVID-19 in humans or animals," and adds that the agency "has determined that currently available clinical trial data do not demonstrate that ivermectin is effective against COVID 19 in humans." The same page summarizes the human approvals as tablets for some parasitic worms plus topical formulations for head lice and skin conditions like rosacea. An FDA warning letter dated 16 March 2023 restated that FDA-approved ivermectin tablets are approved for intestinal strongyloidiasis and onchocerciasis and are available only by prescription. FDA's Center for Veterinary Medicine, in a letter to stakeholders dated 10 April 2020, addressed ivermectin products intended for animals: those products are labeled for animal use only and are not approved for people. Our overview of the approved uses goes through the label in more detail.

NIH. The NIH COVID-19 Treatment Guidelines Panel recommended against the use of ivermectin for the treatment of COVID-19, rating the recommendation AIIa and stating that it was primarily informed by adequately powered randomized trials reporting clinical outcomes. That guideline's final update was 29 February 2024 and the website was shut down on 16 August 2024, with an archived version kept in the National Library of Medicine's web archive collection. Read it as a dated position, not a live one.

CDC. CDC issued a Health Alert Network advisory in August 2021 on the rapid increase in ivermectin prescriptions and reports of severe illness associated with products containing ivermectin taken to prevent or treat COVID-19, including veterinary formulations not intended for human use.

How to search the register yourself for any drug

Go to clinicaltrials.gov and put the drug name in the Intervention/treatment field rather than the general search box. This excludes studies that only mention the drug in passing.
Add a condition if you want one indication, and leave it blank to see the full spread.
Use the filters for study status, study results (with results / without results), phase and location. The result count shown after filtering is your dated number — note the date you ran it.
Open a record and read the primary outcome, the sponsor, the enrollment figure and the "Last Update Posted" date. Check the study record history for changes to the primary outcome.
If the study stopped, read the "Why Study Stopped" text.
Copy the NCT number into PubMed to find any published report tied to that registration.
Remember that not every study anywhere appears here; other countries maintain their own registries, and a drug may have trials recorded elsewhere.

How this page is maintained and dated

Regulatory and label statements on this page were verified against primary sources on 28 September 2026: the DailyMed prescribing information for STROMECTOL (revised 09/2024), SOOLANTRA cream (label updated 24 October 2024) and SKLICE lotion (label updated 11 July 2024); FDA's consumer update (content current 05 April 2024); and the FDA warning letter of 16 March 2023. STROMECTOL was originally approved under NDA 050742 on 22 November 1996.

We do not publish a live count of registered ivermectin trials, and we do not publish prices, because neither can be tied to a dated primary source we can show you. We re-check the FDA, NIH and CDC pages named here and the DailyMed labels on a scheduled basis and change the verification date at the top of this section when we do. This page is informational and names no seller.

Frequently asked questions

Is there an official NIH ivermectin trial?

ACTIV-6 (NCT04885530) is the NIH-supported outpatient platform trial that included ivermectin arms, coordinated by the Duke Clinical Research Institute through PCORnet. Its published platform description reports that it enrolled more than 7,500 participants and reported on ivermectin at two doses.

If a trial is registered for a condition, does that mean FDA is considering approval for it?

No. Registration is a filing with a public register run by the National Library of Medicine. Approval decisions are made by FDA on a new drug application or supplement, and are visible in Drugs@FDA and on the approved label, not on the register.

Why do registered ivermectin trials cover conditions the label does not mention?

Researchers can study an approved drug for a question outside its label under the appropriate regulatory and ethics approvals. That is how evidence is generated. It does not change the label until FDA approves a change — and as of 28 September 2026 the oral label still lists two indications.

What does it mean if a completed trial has no posted results?

It may mean the study was not an "applicable clinical trial" subject to FDAAA 801 results submission, that the sponsor published in a journal instead, that a delay was certified, or that the obligation was simply not met. The absence of posted results is not itself a finding about the drug.

Do trials ever use the ivermectin products sold for livestock and horses?

Ivermectin products labeled for animals — injections, pastes and pour-ons — are approved for animal use only and are not approved for use in people. FDA's Center for Veterinary Medicine addressed this directly in its letter to stakeholders dated 10 April 2020.

Ivermectin Clinical Trials and What the Registered Results Mean