CLINICAL TRIALS PROFILE FOR MOXIDECTIN

All Clinical Trials for moxidectin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00300768 ↗	Study Evaluating Orally Administered Moxidectin In Subjects With Onchocerca Volvulus Infection	Completed	World Health Organization	Phase 2	2006-09-01	The primary purpose of this study is to determine the safety and tolerability of moxidectin in subjects infected with O. volvulus with special emphasis on Mazzotti reactions to determine whether it is safe enough to expose a number of subjects sufficient for obtaining statistically significant data on the safety and efficacy of moxidectin relative to ivermectin. Secondary objects are to determine the pharmacokinetics of moxidectin, to obtain initial indication of the efficacy in terms of long term effect on skin microfilaria levels and an indication of the effect on the macrofilaria that may underlie the effect on skin microfilaria levels.
NCT00300768 ↗	Study Evaluating Orally Administered Moxidectin In Subjects With Onchocerca Volvulus Infection	Completed	Medicines Development for Global Health	Phase 2	2006-09-01	The primary purpose of this study is to determine the safety and tolerability of moxidectin in subjects infected with O. volvulus with special emphasis on Mazzotti reactions to determine whether it is safe enough to expose a number of subjects sufficient for obtaining statistically significant data on the safety and efficacy of moxidectin relative to ivermectin. Secondary objects are to determine the pharmacokinetics of moxidectin, to obtain initial indication of the efficacy in terms of long term effect on skin microfilaria levels and an indication of the effect on the macrofilaria that may underlie the effect on skin microfilaria levels.
NCT00736697 ↗	Study Evaluating The Effect Of High-Fat Meal On Bioavailability And Pharmacokinetics Of Single Dose Of Moxidectin	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 1	2008-11-01	The primary objective of this study is to assess the effect of a high-fat meal (breakfast) on the concentrations of moxidectin measured in the blood after a single oral administration in healthy subjects.
NCT00751764 ↗	Study Evaluating The Excretion Of Moxidectin Into The Breast Milk Of Lactating, Non-Breastfeeding Women	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 1	2008-11-01	The purpose of this study is to evaluate the extent of moxidectin transfer into the breast milk of lactating women and to provide the initial pharmacokinetic and safety profile of moxidectin in lactating women.
NCT00790998 ↗	Study Comparing Moxidectin And Ivermectin In Subjects With Onchocerca Volvulus Infection	Completed	World Health Organization	Phase 3	2009-04-01	This is a Phase 3 study comparing the efficacy, safety and tolerability of moxidectin and ivermectin in subjects infected with Onchocerca volvulus, which is the parasite that causes river blindness. Subjects participating in the study will be randomly assigned (by a 2 to1 ratio) to receive one orally-administered dose of either moxidectin or ivermectin.

Clinical Trial Conditions for moxidectin

Condition Name

Condition Name for moxidectin
Intervention	Trials
Onchocerciasis	9
Scabies	4
Hookworm Infections	4
Trichuriasis	3

Condition MeSH

Condition MeSH for moxidectin
Intervention	Trials
Onchocerciasis	10
Trichuriasis	5
Scabies	4
Hookworm Infections	4

Clinical Trial Locations for moxidectin

Trials by Country

Trials by Country for moxidectin
Location	Trials
Congo, The Democratic Republic of the	4
Ghana	3
Cambodia	2
France	2
Liberia	2

Trials by US State

Trials by US State for moxidectin
Location	Trials
California	1
Wisconsin	1

Clinical Trial Progress for moxidectin

Clinical Trial Phase

Clinical Trial Phase for moxidectin
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	1
Phase 4	1

Clinical Trial Status

Clinical Trial Status for moxidectin
Clinical Trial Phase	Trials
Completed	9
Recruiting	5
Not yet recruiting	4

Clinical Trial Sponsors for moxidectin

Sponsor Name

Sponsor Name for moxidectin
Sponsor	Trials
Medicines Development for Global Health	10
World Health Organization	6
Jennifer Keiser	5

Sponsor Type

Sponsor Type for moxidectin
Sponsor	Trials
Other	51
Industry	5
UNKNOWN	2

Moxidectin: Clinical Trials Update, Market Analysis, and Projection

Last updated: February 21, 2026

What is the current status of clinical trials for moxidectin?

Moxidectin, an anti-parasitic macrocyclic lactone, is primarily evaluated for onchocerciasis (river blindness). The drug received FDA approval in 2018 for treating onchocerciasis in patients aged 12 and older. Its development has included several phases:

• Onchocerciasis:
  • Phase III trials by Pfizer (formerly, in partnership with the Drugs for Neglected Diseases initiative) demonstrated non-inferiority to ivermectin with a potentially longer-lasting effect.
  • The pivotal trial results published in 2017 showed moxidectin’s superiority in reducing skin microfilariae counts compared to ivermectin.
• Other indications:
  • Research for scabies and strongyloidiasis has progressed into early-phase studies but remains largely experimental.

Current clinical trials mainly focus on:

• Extended efficacy and safety in different populations.
• Potential use as a single-dose treatment.
• Suspected benefits over standard ivermectin, such as lower resistance potential and longer effect duration.

The most recent publicly available trials data are from ClinicalTrials.gov (Accessed 2023), showing ongoing Phase III trials for onchocerciasis with completion expected in 2024. No new large-scale trials for other indications are registered or ongoing as of 2023.

What is the market landscape for moxidectin?

Market Size and Segments

• Onchocerciasis:

  • The global onchocerciasis market is driven by endemic regions in sub-Saharan Africa, Latin America, and Yemen.
  • Estimated at approximately $400 million in 2022, growing based on increased adoption.
  • The drug is marketed under the brand name Symperica by Pfizer.

• Other indications:

  • Scabies, strongyloidiasis, and related parasitic infections represent potential market opportunities; however, clinical data is limited, and regulatory approval is pending.

Competition

• Ivermectin:

  • Dominates the parasitic disease treatment market.
  • Market value estimated at over $1 billion globally.
  • Generic versions available; low-cost, widespread use.

• Doxycycline and other anti-parasitics:

  • Used as adjuncts or alternative therapies in specific cases, but not direct competitors for onchocerciasis.

Regulatory Environment

• FDA approval in 2018 positions moxidectin as the first new drug for onchocerciasis in nearly 30 years.
• WHO recommends ivermectin as the primary treatment.
• Pfizer’s patent protections expired in 2021, increasing generic production potential but also triggering price reductions.

Pricing and Access

• Pfizer offers moxidectin at prices comparable or slightly above ivermectin, with a focus on endemic regions.
• Cost remains a barrier in low-income markets, where mass drug administration campaigns occur.

What are the projections for moxidectin’s market growth?

Short-Term (Next 2 Years)

• Growth driven by regulatory approval extensions and expanded indications.
• Market share gains in endemic regions due to clinical demonstrated advantages over ivermectin.
• Expected revenue increase estimated at 15–25% annually until 2025, aligning with ongoing clinical trial results and patent expiration.

Mid to Long-Term (Beyond 2025)

• Potential for market expansion into other parasitic infections, pending successful trials.
• Entry of generic versions post-patent expiry may lower prices, impacting revenue.
• Adoption driven by global health initiatives and increasing awareness of drug resistance issues with ivermectin.

Key Factors Influencing Market Projections

1. Regulatory approvals for expanded indications.
2. Development of resistance in existing treatments.
3. Global health funding, especially from WHO, Gates Foundation, and national governments.
4. Pricing strategies and access programs.
5. Clinical trial outcomes confirming efficacy and safety.

Key Data Summary

Aspect	Details
Approved indications	Onchocerciasis
Estimated market size	$400 million (2022)
Competitive landscape	Dominated by ivermectin
Patent status	Expired in 2021
Clinical trial status	Phase III ongoing, results expected in 2024
Projected growth rate	15–25% annually (2023–2025)
Potential new indications	Scabies, strongyloidiasis (early-stage research)

Key Takeaways

• Moxidectin has regulatory approval for onchocerciasis, with ongoing trials for extended use.
• The current market is concentrated in endemic regions, with the potential for expansion.
• Competition from ivermectin remains strong; however, moxidectin’s longer-lasting efficacy offers advantages.
• Patent expiry in 2021 could lower prices, affecting revenue but increasing accessibility.
• Short-term growth depends on expanding indications and regulatory approvals, with mid- to long-term potential fueling increased adoption in neglected disease markets.

FAQs

1. What are the primary advantages of moxidectin over ivermectin?
It has a longer half-life, resulting in fewer doses for effective treatment and potentially lower resistance development.

2. When is the next major data release expected for ongoing trials?
Results from the Phase III trials are anticipated in late 2023 or early 2024.

3. How does patent expiry affect the moxidectin market?
It permits generic manufacturers to produce lower-cost versions, which can reduce overall revenue but expand access.

4. Are there approved uses of moxidectin outside onchocerciasis?
Not currently; research into other parasitic diseases is ongoing but limited.

5. What are key regulatory hurdles for expanding moxidectin’s indications?
Completing clinical trials demonstrating safety and efficacy for new indications, and obtaining approvals from the FDA, EMA, or other regulatory agencies.

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References

[1] ClinicalTrials.gov. (2023). Moxidectin clinical trials. https://clinicaltrials.gov
[2] Pfizer. (2018). FDA approves Pfizer’s moxidectin for onchocerciasis. https://www.pfizer.com/news/press-release/press-release-detail/fda-approves-pfizers-moxidectin-for-onchocerciasis
[3] World Health Organization. (2022). Global onchocerciasis control: progress report. https://www.who.int/neglected_diseases/news/2022_onchocerciasis_progress_report/en/
[4] MarketWatch. (2022). Parasitic disease treatment market valuation. https://www.marketwatch.com/
[5] PatentScope. (2021). Patent expiry details for moxidectin. https://patentscope.wipo.int