Moxidectin: The Newer River-Blindness Drug

Moxidectin is a single-dose tablet approved in the United States in 2018 for river blindness, the worm infection known in medicine as onchocerciasis. It was a veterinary medicine for years before anyone tested it in people. In the main human trial, skin counts of the parasite's larvae one year after a dose were 86% lower than after ivermectin, the drug that has carried river-blindness programmes for decades. The same trial found reactions to dying larvae in nearly everyone treated with either drug, and the label carries a warning about a serious, possibly fatal brain reaction in people who also carry the eye worm Loa loa. This page reports those findings, the later trials in other worm and mite infections, and what is still unmeasured, including what repeated doses do.

Table of Contents

  1. The Same Family as Ivermectin, a Different Branch
  2. The 2018 Approval and the Label
  3. The Phase 3 Trial Against Ivermectin
  4. Results by Area and by Heaviness of Infection
  5. Once a Year or Twice a Year
  6. Dosing Work in Children
  7. Lymphatic Filariasis Trials
  8. Strongyloidiasis Trials
  9. Scabies: From Pigs to Adults
  10. Whipworm: Results That Vary by Place
  11. Label Warnings and Reported Reactions
  12. The Safety Trial of 12,979 People
  13. A Half-Life Measured in Weeks
  14. Pregnancy, Breastfeeding and Other Groups
  15. What Is Not Known
  16. Key Research Papers
  17. Connections
  18. Featured Videos

The Same Family as Ivermectin, a Different Branch

Moxidectin and ivermectin are both macrocyclic lactones, large ring-shaped molecules that begin as fermentation products of microbes. The label describes moxidectin as a macrocyclic lactone of the milbemycin class, derived from the bacterium Streptomyces cyanogriseus. Ivermectin belongs to the neighbouring avermectin group.

A 2012 review set out the chemistry. Avermectins and milbemycins share the same large ring but come from different organisms. Avermectins carry sugar groups at one position on the ring, milbemycins do not, and moxidectin has a further difference, an added chemical group called a methoxime. The authors reported that moxidectin's longer half-life and its safety profile allow it to be used in long-acting forms. They also reported "profound differences" in how the two groups interact with transporter pumps in mammals and worms, and that resistance to the two groups overlaps in part but is not identical (Prichard and colleagues, 2012).

Laboratory work points in the same direction. When a roundworm chloride channel called GLC-2 was expressed in frog egg cells, moxidectin blocked it roughly 10 times more potently than ivermectin (Kaji and colleagues, 2022). That result comes from isolated cells, not from infected people.

The label states that the way moxidectin acts against the river-blindness parasite is not known. Studies in other roundworms suggest it binds glutamate-gated chloride channels, receptors for gamma-aminobutyric acid, a nerve signal, or certain transporter pumps, leading to paralysis of the worm's muscle. Against the river-blindness worm, the label reports that it is active against the larvae but is not effective in killing the adults, although it inhibits embryo development in the womb of the adult female and the release of new larvae.

The first study in people, published in 2003, describes moxidectin as registered worldwide as a veterinary antiparasitic for companion and farm animals. Healthy men took single doses from 3 to 36 mg (Cotreau and colleagues, 2003).

The 2018 Approval and the Label

United States Food and Drug Administration records list the original approval of moxidectin tablets on 13 June 2018 as a new molecular entity under priority review. The development programme was begun by the World Health Organization through its tropical disease research programme, which ran and funded the phase 2 and phase 3 studies. The World Health Organization then licensed its moxidectin data to a not-for-profit organization, which became the regulatory sponsor (Kura and colleagues, 2023; Ngave and colleagues, 2026).

The label, in its current form, reports these facts:

The Phase 3 Trial Against Ivermectin

River blindness is measured by counting microfilariae, the parasite's microscopic larvae, in small snips of skin. The infection passes between people through the bites of blackflies (Tan and colleagues, 2022), and the phase 3 authors describe these skin larvae as the reservoir for that transmission (Opoku and colleagues, 2018).

The phase 3 trial was double-blind and took place at four sites in Ghana, Liberia and the Democratic Republic of the Congo. Enrolment ran from April 2009 to January 2011. Participants were aged 12 or older, had at least 10 microfilariae per mg of skin, and did not have Loa loa or lymphatic filariasis larvae in their blood. The trial gave a single 8 mg dose of moxidectin to 978 people and a single 150 µg/kg dose of ivermectin to 494, of whom 947 and 480 were in the main analysis (Opoku and colleagues, 2018).

At 12 months, the adjusted geometric mean was 0.6 microfilariae per mg of skin after moxidectin (95% confidence interval 0.3 to 1.0) and 4.5 after ivermectin (3.5 to 5.9). The difference was 3.9 (p<0.0001), a treatment difference of 86% (Opoku and colleagues, 2018).

The label reports the same trial with simple averages, starting from a mean of 39.5 microfilariae per mg of skin before treatment, with 977 people counted for moxidectin and 495 for ivermectin:

Mazzotti reactions, the itching, rash, fever and other effects caused by the body's response to dying larvae, occurred in 967 of 978 people on moxidectin (99%) and 478 of 494 on ivermectin (97%). Clinical reactions occurred in 97% and 90%, eye reactions in 12% and 10%, and laboratory reactions in 81% and 84%. No serious adverse event was considered related to treatment (Opoku and colleagues, 2018).

A smaller earlier study in Ghana followed participants for 18 months. Average counts after 8 mg moxidectin (38 people) and ivermectin (45 people) started at 22.9 and 21.2. At 6 months they were 0.0 and 1.6, at 12 months 0.4 and 3.4, and at 18 months 1.8 and 4.0. Itching (87% against 56%), rash (63% against 42%) and a fall in blood pressure on standing (61% against 27%) were more frequent after 8 mg moxidectin, and these reactions resolved without treatment (Awadzi and colleagues, 2014).

Results by Area and by Heaviness of Infection

A later analysis of the phase 3 trial broke the 12-month results down. The treatment difference was 92.9% in Nord Kivu, 90.1% in Ituri, 86.8% in Lofa and 84.5% in Nkwanta. It rose with the starting infection: 74.1%, 84.2%, 90.0% and 95.4% across four bands from lightest to heaviest (Bakajika and colleagues, 2022).

The authors also counted a suboptimal response, defined as a 12-month count above 40% of the starting count. Across the same four areas this occurred in 0%, 0.3%, 1.6% and 3.9% of people given moxidectin, and in 12.1%, 23.7%, 10.8% and 28.0% of people given ivermectin. These participants had never been through community ivermectin programmes, so the authors raised the possibility that parasite populations differ in drug susceptibility without earlier drug pressure (Bakajika and colleagues, 2022).

The disease itself may also be shifting under the trials. Screening for two newer moxidectin studies in Logo, Ituri, found no larvae in 89.8% of adults and 96.8% of adolescents in 2021 to 2023, against 23.3% and 26.9% in 2010, in an area where mass ivermectin treatment was never carried out. The authors attribute the fall to reduced biting by infective flies, possibly linked to changes in land use (Ngave and colleagues, 2026).

Once a Year or Twice a Year

The direct comparison has been run, but its results were not available at the time of writing. A double-blind trial in the Democratic Republic of the Congo, with 323 participants, randomly assigned 8 mg moxidectin or about 150 µg/kg ivermectin, each given once or twice a year for 24 months. Its primary measure is how many people given moxidectin yearly or twice yearly keep a sustained response at 12 months. The registry lists primary data collection as finished in July 2024 and the study as still active, with no results posted (ClinicalTrials.gov NCT03876262). No published results were found in the literature searches for this page.

What exists so far is modelling. A transmission model projected that twice-yearly moxidectin could halve the years needed to stop transmission in areas of moderate infection and might be the only strategy able to reach that goal in heavily infected areas. The authors list the effect of repeated annual and twice-yearly moxidectin first among the data still needed (Kura and colleagues, 2023).

An economic model using the same transmission model found that moxidectin strategies generally reached the goal at lower delivery cost than yearly ivermectin. The exception was yearly moxidectin at minimal coverage, which did not reach the goal in heavily infected areas within 40 years. Those delivery costs exclude the price of the drug itself, and the authors state that drug costs are needed to judge overall programme cost (Turner and colleagues, 2024).

A cluster-randomised trial in Angola, registered with a target of 52,000 people, is comparing yearly moxidectin and yearly ivermectin given to whole communities, and is also looking at intestinal worms and scabies. The registry lists it as recruiting, with primary completion estimated for 2029 (ClinicalTrials.gov NCT07145736).

Dosing Work in Children

The dose finding for younger children rests on a small study in an endemic area of Ghana. It was open-label, with no comparison drug, and gave a single dose to four groups of nine: 8 mg at ages 12 to 17, 8 mg at ages 8 to 11, 6 mg at ages 8 to 11, and 4 mg at ages 4 to 7. There were 38 adverse events in 24 participants. They were illnesses common in that population, mainly malaria, and were considered not related to moxidectin. Blood exposure in all groups stayed below that of healthy adults given 36 mg, the highest dose tested in people. The authors selected 8 mg for ages 8 to 11 and 4 mg for ages 4 to 7 for further study (Opoku and colleagues, 2025).

The label uses weight bands instead of those age groups and lists simulated exposures for them. It also reports that Mazzotti reactions were not seen in these 36 children, whose infection status was unknown, and that the most common adverse reactions were abdominal pain and diarrhea, in 3 of 36 each. Use in younger children is supported by trials in people aged 12 and older plus this exposure and safety information. Safety and effectiveness below age 4 or below 13 kg have not been established.

Lymphatic Filariasis Trials

Moxidectin is not labelled for lymphatic filariasis, the worm infection behind hydrocele and lymphedema. A trial in Côte d'Ivoire tested it for the first time in people with Wuchereria bancrofti larvae in their blood. It was open-label with masked observers, and randomly assigned 164 adults to single-dose combinations with albendazole.

Only 113 of the 164 participants met the efficacy criteria and completed follow-up, so these fractions are small (Koudou and colleagues, 2025).

In the first week after treatment, 53% of participants had a mild or moderate adverse event. Four participants on ivermectin regimens had short-lived blood in the urine graded as grade 3. There were no serious adverse events, and no significant difference between the groups (Bjerum and colleagues, 2023). Blood-level measurements in 58 of the participants fell within the range taken to mean no drug interaction (Chhonker and colleagues, 2023).

A larger randomised trial in Fiji comparing three-drug regimens given to whole communities, with a registered target of 5,100 people, also covers scabies and strongyloidiasis. The registry lists it as recruiting (ClinicalTrials.gov NCT07159373).

Strongyloidiasis Trials

Strongyloides stercoralis is a soil-transmitted roundworm able to reinfect the same person from within. Moxidectin is not labelled for it. A placebo-controlled dose-ranging trial in northern Laos randomly assigned 223 adults to 2 to 12 mg or placebo. Predicted cure rates were 14% on placebo, 75% at 2 mg, 83% at 4 mg, 86% at 6 mg and 87% at 8 mg, levelling off at 88% at 10 and 12 mg. No serious adverse events were recorded (Hofmann and colleagues, 2021).

A larger double-blind trial in Laos and Cambodia then compared 8 mg moxidectin with 200 µg/kg ivermectin in 726 adults. Cure 14 to 21 days after treatment was 93.6% with moxidectin (324 of 346) and 95.7% with ivermectin (335 of 350). The difference of -2.1 percentage points (95% confidence interval -5.5 to 1.3) met the trial's limit for non-inferiority, set at -10 points. Abdominal pain occurred in 9% in both groups and headache in 7% and 8%, mostly mild and short-lived (Sprecher and colleagues, 2024).

A systematic review found only these two trials to compare, with 821 adults in total. The odds ratio for cure was 0.67 (95% confidence interval 0.36 to 1.25), and the certainty of the evidence was rated moderate. Neither trial included people with weakened immune systems. The authors reported the data as insufficient for people with immune disorders and for the very young or very old (Henriquez-Camacho and colleagues, 2024). Modelling from the Laos data supported a fixed dose over weight-based dosing (Smit and colleagues, 2022) and proposed, as an untested idea, two doses three weeks apart to cover the worm's self-reinfection cycle (Hofmann and colleagues, 2022).

The site's page on ivermectin for strongyloidiasis covers the comparison drug.

Scabies: From Pigs to Adults

The scabies work began in animals. In pigs with scabies, four animals given a single dose of moxidectin were all free of mites by day 14 and stayed free to day 47, while only two of the pigs given two doses of ivermectin were mite-free at day 14. Moxidectin persisted about nine times longer in the blood and skin of these pigs (Bernigaud and colleagues, 2016).

The human results found for this page are in a trial registry, not yet in a journal article found in the searches. The larger entry states that the drug is not approved for scabies in people.

Registry entries do not go through journal peer review. The site's page on scabies covers the disease itself.

Whipworm: Results That Vary by Place

Whipworm trials show large differences between settings, with moxidectin almost always given alongside albendazole.

Stool sequencing from a Côte d'Ivoire trial of 204 people found shifts in gut bacteria after albendazole and after moxidectin plus albendazole, with only mild functional consequences, and more pronounced changes at higher ivermectin doses (Dommann and colleagues, 2026). The site also has a page on ivermectin and the gut microbiome.

Label Warnings and Reported Reactions

The label carries four warnings.

Mazzotti reaction. Treatment may cause skin, eye and whole-body reactions of varying severity, due to allergic and inflammatory responses to the death of the larvae. The label reports a trend toward more of these reactions in people with a heavier larval burden. Listed signs include itching, headache, fever, rash, hives, low blood pressure, fast heartbeat, swelling, swollen lymph nodes, joint and muscle pain, chills, tingling and weakness. Eye signs include redness, pain, itching, eyelid swelling, blurred vision, light sensitivity and changes in sharpness of vision. They generally occur and resolve in the first week. Treatment of severe reactions has not been tested in controlled trials.

Low blood pressure on standing. In the phase 3 trial, 47 of 978 people on moxidectin (5%) and 8 of 494 on ivermectin (2%) became unable to stand without support after lying down for 5 minutes, in a test designed to provoke the effect. The drops were temporary and most common on days 1 and 2. The label's instruction to patients is to lie down if dizzy or light-headed until the symptoms pass.

Brain reaction with Loa loa. People with river blindness who also carry Loa loa "may develop a serious or even fatal encephalopathy" after treatment, the label states. Moxidectin has not been studied in people with both infections, and the phase 3 trial excluded them. The label recommends diagnostic screening for loiasis before treatment in people exposed to areas where Loa loa occurs. Severe reactions in people with high Loa loa counts have also occurred after ivermectin (Wafeu and colleagues, 2024).

One small trial has looked at this question from the Loa loa side. In Cameroon, 72 men with low counts (5 to 1,000 larvae per mL of blood) were randomly assigned to 2 mg moxidectin, one quarter of the labelled adult dose, or standard ivermectin. There were no serious or severe events. Grade 2 events were less frequent with moxidectin (14.3% against 38.5%), and larval counts fell less (48.1% against 79.8% at day 30). The authors stated that higher doses and people with higher counts remain to be studied (Wafeu and colleagues, 2024). In the Democratic Republic of the Congo, overlap with Loa loa is reported as a major barrier to safe mass treatment (Makenga Bof, 2026).

Swelling and worse skin disease. People with a hyper-reactive skin form of river blindness, called sowda, may be more likely to have severe swelling and worsening of the skin condition.

The most frequent reactions in the phase 3 trial, as tabulated in the label for moxidectin and ivermectin respectively, were high eosinophil count (74%, 79%), itching (65%, 54%), muscle and joint pain (64%, 52%), headache (58%, 54%), low lymphocyte count (48%, 44%), fast heartbeat (39%, 30%) and rash (37%, 21%). Bilirubin above the normal limit occurred in 2.8% and 0.6%. The liver enzyme alanine aminotransferase above five times the normal limit occurred in 1% and 0.4%. Eye pain occurred in 8% and 6%, and vision impairment in 3% and 2%.

A further analysis of the phase 3 trial found the two drugs had the same effect on larvae in the front of the eye. Counts there rose by day 4 in 20% of participants and by month 1 in 16%. The risk of an eye reaction was higher in women (odds ratio 1.537) and with more larvae in the eye before treatment (Kanza and colleagues, 2024).

The Safety Trial of 12,979 People

A double-blind phase 3b safety trial enrolled 12,979 people aged 4 and over living in river-blindness areas, including people with few or no larvae (Ngave and colleagues, 2026). Results posted on the trial registry compare a single dose of moxidectin with ivermectin over 3 months, some participants also taking albendazole. No journal publication of the results was found in the searches for this page. Pooled figures, with percentages calculated here:

Source: ClinicalTrials.gov NCT04311671.

A Half-Life Measured in Weeks

Half-life is the time the body takes to clear half of a drug. In people with river blindness, the label gives a mean final half-life of 23.3 days (559 hours) after 8 mg. In healthy volunteers it lists 784 hours. The first human study reported mean values of 20.2 to 35.1 days across doses (Cotreau and colleagues, 2003). Blood levels peaked about 4 hours after dosing, and severity of infection did not change the drug's handling (Tan and colleagues, 2022).

The label gives related figures: an apparent volume of distribution of 2,421 litres in people with river blindness, 99.92% binding to blood proteins, minimal liver metabolism and negligible kidney removal of intact drug. After a single dose in healthy people, 2% of the dose left unchanged in the stool within 72 hours. Simulated half-lives for children in the label were shorter at lower weights: 299, 338 and 546 hours across the three weight bands.

A review describes stronger and longer suppression of larvae than ivermectin in phase 2 and 3 trials (Milton and colleagues, 2020). A heart study in 60 healthy men found no significant effect on the QT interval, a heart-rhythm measure, at doses up to 36 mg (Kinrade and colleagues, 2018). The first human study reported slightly more short-lived mild and moderate nervous system complaints as the dose rose (Cotreau and colleagues, 2003). The label reports temporary nervous system signs in rats and dogs at high doses.

Pregnancy, Breastfeeding and Other Groups

Pregnancy. The label states that human data are insufficient to establish a risk of birth defects or miscarriage. In rats, a dose about 15 times the human dose by body surface raised cleft palate in fetuses, at a dose also toxic to the mothers. Dosing rat mothers through nursing at less than twice the human dose lowered pup survival and body weight.

Breastfeeding. Moxidectin was detected in the milk of 12 healthy women after a single 8 mg dose. The label states that breastfeeding is not recommended at the time of treatment and for 7 days after it, because of the serious rat findings. A later modelling paper, with authors from the sponsor and its consultants, reported concentrations in milk below acceptable intake thresholds as early as two days after dosing (Wood and colleagues, 2024). The effects on a nursing child have not been measured.

Kidneys and liver. No dose change is listed for mild or moderate kidney impairment. Severe kidney impairment and liver impairment are listed as unknown.

Overdose. The label reports that no specific antidote exists and describes supportive care.

What Is Not Known

Key Research Papers

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  2. Awadzi K, Opoku NO, Attah SK, Lazdins-Helds J, Kuesel AC. A randomized, single-ascending-dose, ivermectin-controlled, double-blind study of moxidectin in Onchocerca volvulus infection. PLoS Negl Trop Dis. 2014;8(6):e2953. PubMed PMID: 24968000
  3. Bakajika D, Kanza EM, Opoku NO, Howard HM, Mambandu GL, Nyathirombo A, Nigo MM, Kennedy KK, Masembe SL, Mumbere M, Kataliko K, Bolay KM, Attah SK, Olipoh G, Asare S, Vaillant M, Halleux CM, Kuesel AC. Effect of a single dose of 8 mg moxidectin or 150 μg/kg ivermectin on O. volvulus skin microfilariae in a randomized trial: Differences between areas in the Democratic Republic of the Congo, Liberia and Ghana and impact of intensity of infection. PLoS Negl Trop Dis. 2022;16(4):e0010079. PubMed PMID: 35476631
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  28. Keller L, Palmeirim MS, Ame SM, Ali SM, Puchkov M, Huwyler J, Hattendorf J, Keiser J. Efficacy and Safety of Ascending Dosages of Moxidectin and Moxidectin-albendazole Against Trichuris trichiura in Adolescents: A Randomized Controlled Trial. Clin Infect Dis. 2020;70(6):1193-1201. PubMed PMID: 31044235
  29. Welsche S, Mrimi EC, Hattendorf J, Hürlimann E, Ali SM, Keiser J. Efficacy and safety of moxidectin and albendazole compared with ivermectin and albendazole coadministration in adolescents infected with Trichuris trichiura in Tanzania: an open-label, non-inferiority, randomised, controlled, phase 2/3 trial. Lancet Infect Dis. 2023;23(3):331-340. PubMed PMID: 36354034
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Regulatory and Trial Registry Records

  1. Moxidectin tablets, United States prescribing information, DailyMed, National Library of Medicine. All statements on this page attributed to the label come from this record, with changes dated February 2025.
  2. Drugs@FDA, application 210867, United States Food and Drug Administration. Original approval 13 June 2018; efficacy supplement 7 February 2025.
  3. ClinicalTrials.gov NCT03876262. Annual or twice-yearly doses of moxidectin or ivermectin, Democratic Republic of the Congo.
  4. ClinicalTrials.gov NCT04311671. Safety of a single dose of moxidectin compared with ivermectin, results posted February 2026.
  5. ClinicalTrials.gov NCT03905265. Dose-finding study in adults with scabies, results posted September 2023.
  6. ClinicalTrials.gov NCT05875441. Placebo-controlled dose-ranging trial in adults with scabies, results posted June 2026.
  7. ClinicalTrials.gov NCT07145736. Mass treatment with moxidectin or ivermectin, Angola.
  8. ClinicalTrials.gov NCT07159373. Mass treatment for lymphatic filariasis, scabies and strongyloidiasis, Fiji.

PubMed Topic Searches

  1. PubMed: moxidectin and onchocerciasis
  2. PubMed: moxidectin and lymphatic filariasis
  3. PubMed: moxidectin and strongyloidiasis
  4. PubMed: moxidectin and scabies
  5. PubMed: moxidectin and whipworm
  6. PubMed: moxidectin and Loa loa

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