CLINICAL TRIALS PROFILE FOR MOXIDECTIN

All Clinical Trials for moxidectin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00790998 ↗	Study Comparing Moxidectin And Ivermectin In Subjects With Onchocerca Volvulus Infection	Completed	Medicines Development for Global Health	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.
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.
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.

Clinical Trial Conditions for moxidectin

Condition Name

Condition Name for moxidectin
Intervention	Trials
Onchocerciasis	8
Hookworm Infections	3
Trichuriasis	3
Ascariasis	3

Condition MeSH

Condition MeSH for moxidectin
Intervention	Trials
Onchocerciasis	9
Trichuriasis	4
Hookworm Infections	3
Ascariasis	3

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
Wisconsin	1

Clinical Trial Progress for moxidectin

Clinical Trial Phase

Clinical Trial Phase for moxidectin
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	7
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for moxidectin
Clinical Trial Phase	Trials
Completed	8
Not yet recruiting	4
Recruiting	4

Clinical Trial Sponsors for moxidectin

Sponsor Name

Sponsor Name for moxidectin
Sponsor	Trials
Medicines Development for Global Health	8
World Health Organization	5
Jennifer Keiser	5

Sponsor Type

Sponsor Type for moxidectin
Sponsor	Trials
Other	38
Industry	4

Moxidectin: Clinical Trials, Market Analysis, and Projections

Introduction to Moxidectin

Moxidectin is a promising antiparasitic drug developed by Medicines Development for Global Health (MDGH), a non-profit pharmaceutical company focused on treating diseases prevalent in low- and middle-income countries. Here, we will delve into the current status of clinical trials, market analysis, and future projections for moxidectin.

Clinical Trials Update

Moxidectin for Onchocerciasis (River Blindness)

Moxidectin has already received US FDA approval in 2018 for the treatment of onchocerciasis, a neglected tropical disease causing blindness and severe skin irritation. Post-approval, several clinical trials have been conducted to facilitate its inclusion in WHO treatment guidelines. These trials have shown that moxidectin provides a more consistent and durable suppression of O. volvulus microfilariae compared to ivermectin, the current standard treatment[2][4].

Moxidectin for Scabies

Clinical trials for moxidectin as a treatment for scabies are ongoing. A Phase 2a dose-finding study (MDGH-MOX-2001) was completed in February 2022, and start-up activities for a Phase 2b dose confirmatory study (MDGH-MOX-2002) are underway. This multicentre, multi-country study compares different doses of moxidectin to ivermectin, with primary efficacy outcomes measured by the proportion of subjects with complete cure by Day 28[1][4].

Moxidectin for Lymphatic Filariasis

Additionally, moxidectin is being investigated for the treatment of lymphatic filariasis. A recently completed Phase 2 study sponsored by the Death to Onchocerciasis and Lymphatic Filariasis (DOLF) project showed promising results. A Phase 3 study to evaluate the safety and efficacy of moxidectin combination regimens compared to ivermectin, diethylcarbamazine, and albendazole is planned for 2025[4].

Market Analysis

Current Market Position

Moxidectin is poised to replace ivermectin in many areas, particularly in hyperendemic settings where ivermectin's efficacy is limited. The drug has achieved US FDA approval and is undergoing the World Health Organization's pre-qualification (PQ) process, which is expected to enhance its adoption globally[2][4].

Market Size and Growth

The global moxidectin market is expected to grow significantly, driven by the increasing need for effective treatments for neglected tropical diseases. Market research reports indicate that the moxidectin injection market will see substantial growth due to its efficacy and the expanding demand for antiparasitic treatments[5].

Competitive Landscape

Moxidectin is the first promising alternative to ivermectin, offering a more consistent and durable suppression of microfilariae. This positions moxidectin as a key player in the antiparasitic drug market, particularly in regions where ivermectin's limitations are most pronounced[2][4].

Projections and Future Outlook

WHO Pre-Qualification and Adoption

MDGH is expected to receive WHO pre-qualification for moxidectin by the end of 2026, which will significantly boost its adoption in many countries. It is forecasted that at least 10 countries will include moxidectin as a first-line treatment option for onchocerciasis by 2035[2].

Disease Elimination Potential

Moxidectin is projected to accelerate the elimination of onchocerciasis transmission in areas of moderate endemicity and may be the only strategy capable of achieving elimination in hyperendemic areas. This potential for disease elimination makes moxidectin a critical tool in global health initiatives[4].

Financial and Operational Projections

The grant from GiveWell to support the WHO PQ process for moxidectin is a significant step forward. MDGH plans to take moxidectin to market, with a pilot field implementation project set to commence in Ghana in early 2025. The financial projections indicate that the funds used for moxidectin will have a counterfactual value equal to standard benchmarks for government health spending and donated deworming drugs[2].

Challenges and Reservations

Regulatory and Implementation Challenges

While moxidectin shows great promise, there are challenges ahead. MDGH may encounter unanticipated difficulties or delays during the WHO PQ process, and national governments may choose not to adopt moxidectin even after it is brought to market[2].

Manufacturing and Distribution

MDGH currently sub-contracts the manufacturing of moxidectin but manages the manufacturing process. Ensuring scalable and reliable manufacturing and distribution will be crucial for the widespread adoption of moxidectin[2].

Key Takeaways

• Clinical Trials: Moxidectin is undergoing various clinical trials for onchocerciasis, scabies, and lymphatic filariasis, showing promising results.
• Market Position: Moxidectin is set to replace ivermectin in many hyperendemic areas due to its superior efficacy.
• WHO Pre-Qualification: Expected to receive WHO PQ by the end of 2026, enhancing global adoption.
• Disease Elimination: Has the potential to accelerate the elimination of onchocerciasis transmission.
• Financial Projections: Supported by grants and expected to have significant counterfactual value.

FAQs

Q: What is moxidectin used for?

A: Moxidectin is used for the treatment of onchocerciasis (river blindness), scabies, and is being investigated for lymphatic filariasis.

Q: Has moxidectin received FDA approval?

A: Yes, moxidectin received US FDA approval in 2018 for the treatment of onchocerciasis.

Q: What is the current status of clinical trials for moxidectin in scabies?

A: A Phase 2b dose confirmatory study is underway, comparing moxidectin to ivermectin.

Q: Why is WHO pre-qualification important for moxidectin?

A: WHO pre-qualification enhances the likelihood of moxidectin being adopted by many countries due to its validation of quality, safety, and efficacy.

Q: What are the potential challenges for the adoption of moxidectin?

A: Challenges include unanticipated difficulties during the WHO PQ process and potential reluctance from national governments to adopt the drug.

Sources

1. Medicines Development for Global Health. "Moxidectin for scabies: clinical study updates." December 21, 2022.
2. GiveWell. "Medicines Development for Global Health (MDGH) — Moxidectin WHO pre-qualification grant." November 2024.
3. Tandfonline. "Moxidectin: an oral treatment for human onchocerciasis." 2020.
4. Medicines Development for Global Health. "An update on the progress of our major programs." October 16, 2024.
5. QYResearch. "Global Moxidectin Injection Market Insights, Forecast to 2030." February 7, 2024.