NCT02533336
- Objective
- Not yet disclosed
- Design
- Not yet disclosed
- Participants
- Not yet disclosed
- Primary endpoint
- Not yet disclosed
- Results
- Results not yet reported; trial terminated February 5, 2019
pharma · Breast Cancer · Prostate Cancer · UTHR
United Therapeutics Europe
United Therapeutics Europe Ltd
United Therapeutics is a pharma organization headquartered in Silver Spring, USA. It trades on NYSE under ticker UTHR. Primary therapeutic focus areas include Breast Cancer, Prostate Cancer, Pulmonary Arterial Hypertensi
1000 Spring Street, Silver Spring, Maryland 20910, US HQ
1996 Founded
1,443 Employees
Public company Type
UTHR · NYSE Ticker
Company details
- Status
- Public
- HQ
- 1000 Spring Street, Silver Spring, Maryland 20910, US
- Founded
- 1996
- Employees
- 1,443
- Programs
- 1032
- Drugs
- 612
- Patents
- 3720
abamectin and fenpyroximate
Phase 3 · small molecule · Malaria
Abamectin and fenpyroximate is a small-molecule combination therapy developed by United Therapeutics Europe Ltd for the treatment of malaria. The program, internally designated as the DL Project in Tanzania, reached Phase 3 clinical development but was terminated as of February 2019. The combination represents an inves
Internal code DL Project in Tanzania
At a glance
- Sponsor
- United Therapeutics Europe Ltd
- Phase
- Phase 3
- Modality
- small_molecule
- Indication
- Malaria
- Status
- terminated
- Trials
- 1
Executive summary
Abamectin and fenpyroximate is a small-molecule combination therapy developed by United Therapeutics Europe Ltd for the treatment of malaria. The program, internally designated as the DL Project in Tanzania, reached Phase 3 clinical development but was terminated as of February 2019. The combination represents an investigational approach to malaria treatment, evaluated against a backdrop of established antimalarial therapies including artemether-lumefantrine combinations (Coartem), chloroquine, amodiaquine, and sulfadoxine-pyrimethamine. The mechanism of action and specific molecular targets of this combination have not been disclosed. The program's termination in early 2019 marked the end of clinical development for this particular therapeutic approach in the malaria indication.
Why this program matters
Malaria remains a significant global health burden, particularly in sub-Saharan Africa where the Tanzania-based trial was conducted. The development of new antimalarial therapies is clinically relevant given emerging drug resistance to established treatments and the need for alternative options with favorable efficacy and safety profiles. The competitive landscape for malaria treatment includes multiple approved regimens such as artemether-lumefantrine combinations, which are widely used as first-line therapies, as well as investigational agents like tafenoquine (GlaxoSmithKline, Phase 3) that target specific malaria parasites or transmission stages. The termination of the abamectin and fenpyroximate program suggests that clinical or commercial factors rendered the combination less attractive than existing or competing alternatives. Understanding why this program was discontinued provides insight into the current standards of efficacy, safety, and commercial viability expected in the antimalarial space. The program's failure to advance highlights the competitive pressures and regulatory expectations facing new antimalarial candidates.
Drug intelligence
Drug Class: Antimalarial small-molecule combination therapy
Modality: Small molecule
Components: Abamectin and fenpyroximate
Mechanism of Action: Not yet disclosed
Molecular Target: Not yet disclosed
Route of Administration: Not yet disclosed
Related Therapies: Artemether-lumefantrine (Coartem), amodiaquine, artesunate, chloroquine, sulfadoxine-pyrimethamine, primaquine, and tafenoquine represent the broader antimalarial treatment landscape.
Patent Status: Not yet disclosed
First Approval: Program was terminated; no approval achieved
malaria
Prevalence: Point prevalence: 1-9 / 100 000 (Europe) — source: Orphanet, validated.
Overview
Malaria is a serious and sometimes fatal disease caused by a parasite that commonly infects a certain type of mosquito which feeds on humans. Infection with malaria parasites may result in a wide variety of symptoms, ranging from absent or very mild symptoms to severe disease and even death. People who get malaria are typically very sick with high fevers, shaking chills, and flu-like illness. In general, malaria is a curable disease if diagnosed and treated promptly and correctly.Treatment depends on many factors including disease severity, the species of malaria parasite causing the infection and the part of the world in which the infection was acquired.
Treatment landscape
ClinicalTrials.gov lists 860 registered studies for Malaria (AACT aggregate).
Phase breakdown: NA (334), PHASE1 (158), PHASE4 (123), PHASE3 (108), PHASE2 (78), PHASE1/PHASE2 (41), PHASE2/PHASE3 (15), EARLY_PHASE1 (3)
Common investigational therapies:
- Placebo
- PfSPZ Vaccine
- Primaquine
- Artesunate
- Artemether-lumefantrine
- Chloroquine
- Artemether-lumefantrine combination
- dihydroartemisinin-piperaquine
- Amodiaquine
- PfSPZ Challenge
Disease data sourced from MONDO Disease Ontology (MONDO:0005136), Orphanet — malaria, NCT00001645, NCT00075049, NCT00111163, NCT00114010, NCT00115921, AACT (ClinicalTrials.gov aggregate), ClinicalTrials.gov, Open Targets Platform (CC BY 4.0).
Clinical development timeline
- Phase 3TBD
Phase 3 trial ongoing
DL Project in Tanzania evaluating abamectin and fenpyroximate in Phase 3 clinical development.
- Phase 32019-02-05
Program terminated
Development program terminated as of February 5, 2019.
Competitive landscape
The antimalarial market is dominated by established small-molecule therapies, most notably artemether-lumefantrine combinations (Coartem, artemether-lumefantrine ALN), which are approved first-line treatments. Additional approved comparators include chloroquine, amodiaquine, artesunate, and sulfadoxine-pyrimethamine. In the investigational space, tafenoquine (GlaxoSmithKline) is in Phase 3 development, as is artemether-lumefantrine (Avenue Therapeutics) and ITDCVC98 (United Therapeutics Europe Ltd). The termination of the abamectin and fenpyroximate program suggests it did not demonstrate sufficient clinical advantage, safety profile, or commercial potential relative to these established and emerging alternatives. The competitive pressure from multiple approved artemisinin-based combination therapies and the advancement of newer agents like tafenoquine likely contributed to the program's discontinuation.
| Therapy | Company | Mechanism | Status |
|---|---|---|---|
| Chloroquine | United Therapeutics Europe Ltd | small_molecule | approved |
| Amodiaquine plus Artesunate co-administration | United Therapeutics Europe Ltd | small_molecule | approved |
| artemether lumefantrine | United Therapeutics Europe Ltd | small_molecule | approved |
| artemether-lumefantrine (ALN) | United Therapeutics Europe Ltd | small_molecule | approved |
| Coartem™ (Artemether-lumefantrine combination) | United Therapeutics Europe Ltd | small_molecule | approved |
| Sulfadoxine-pyrimethamine | United Therapeutics Europe Ltd | small_molecule | approved |
| Artesunate-amodiaquine combination | United Therapeutics Europe Ltd | small_molecule | approved |
| primaquine | Repatha | small_molecule | approved |
| AL (Coartem) | United Therapeutics Europe Ltd | small_molecule | approved |
| Tafenoquine | GlaxoSmithKline | small_molecule | phase_3 |
| Artemether-lumefantrine | AVENUE THERAPEUTICS, INC. | small_molecule | phase_3 |
| ITDCVC98 | United Therapeutics Europe Ltd | small_molecule | phase_3 |
| QUINIDINE GLUCONATE | — | Sodium channel alpha subunit blocker | Approved |
| HYDROXYCHLOROQUINE SULFATE | — | Toll-like receptor 7 antagonist | Approved |
| HYDROXYCHLOROQUINE | — | Toll-like receptor 7 antagonist | Approved |
| DOXYCYCLINE | — | Matrix metalloproteinase 8 inhibitor | Approved |
| DEXAMETHASONE | — | Glucocorticoid receptor agonist | Phase 3 |
| CYTARABINE | — | DNA polymerase (alpha/delta/epsilon) inhibitor | Phase 3 |
| ACETAMINOPHEN | — | Cyclooxygenase inhibitor | Phase 3 |
| PENTOXIFYLLINE | — | 3',5'-cyclic phosphodiesterase inhibitor | Phase 2 |
Additional associated therapies sourced from Open Targets Platform (CC0), linked to NovaPharmaNews drug profiles where matched.
Regulatory intelligence
FDA Status: Not yet disclosed
EMA Status: Not yet disclosed
PMDA (Japan) Status: Not yet disclosed
NMPA (China) Status: Not yet disclosed
Development History: The program reached Phase 3 clinical evaluation in Tanzania but was terminated on February 5, 2019, prior to any regulatory submission or approval. No regulatory pathway, breakthrough designation, or accelerated review status has been disclosed.
Clinical evidence summary
Key questions answered
What is abamectin and fenpyroximate used for?
Abamectin and fenpyroximate was an investigational combination therapy being developed for the treatment of malaria.
Is abamectin and fenpyroximate approved?
No. The program was terminated in February 2019 during Phase 3 clinical development and never received regulatory approval.
Who is developing abamectin and fenpyroximate?
United Therapeutics Europe Ltd is the sponsor of this program, internally designated as the DL Project in Tanzania.
What is the mechanism of action of abamectin and fenpyroximate?
The mechanism of action has not been disclosed in available sources.
What is the molecular target of this combination?
The specific molecular target or targets have not been disclosed.
What clinical trial supported this program?
NCT02533336 was the registered trial identifier, conducted in Tanzania as part of the DL Project; detailed trial design and results have not been disclosed.
Why was the program terminated?
The specific reasons for termination in February 2019 have not been disclosed; however, termination during Phase 3 typically reflects inadequate efficacy, safety concerns, or commercial viability issues.
What competitors exist in the malaria treatment space?
Approved competitors include artemether-lumefantrine (Coartem), chloroquine, amodiaquine, artesunate, sulfadoxine-pyrimethamine, and primaquine. Investigational competitors in Phase 3 include tafenoquine (GSK), artemether-lumefantrine (Avenue Therapeutics), and ITDCVC98 (United Therapeutics).
What is the route of administration?
The route of administration has not been disclosed.
What is the drug modality?
Abamectin and fenpyroximate is a small-molecule combination therapy.
When was the program first disclosed?
The first disclosure date has not been documented in available sources.
Does United Therapeutics have other antimalarial programs?
Yes. United Therapeutics Europe Ltd is also developing ITDCVC98, which is in Phase 3 clinical development for malaria.
What is the patient population for this therapy?
The specific patient population targeted by this combination has not been disclosed; however, the trial was conducted in Tanzania, suggesting focus on endemic malaria populations.
Is there a partnership or license agreement?
No partner or license arrangement has been disclosed; United Therapeutics Europe Ltd is listed as the sole sponsor.
What regulatory approvals were sought?
Regulatory approval pathways and jurisdictions targeted have not been disclosed.
What is the projected peak sales potential?
Peak sales projections have not been disclosed.
Entity relationship graph
abamectin and fenpyroximate → Drug → Target → Indication → Company → Trials → Competitors
Companies
Indication
Trials
Competitors
- Chloroquine
- Amodiaquine plus Artesunate co-administration
- artemether lumefantrine
- artemether-lumefantrine (ALN)
- Coartem™ (Artemether-lumefantrine combination)
- Sulfadoxine-pyrimethamine
- Artesunate-amodiaquine combination
- primaquine
- AL (Coartem)
- Tafenoquine
- Artemether-lumefantrine
- ITDCVC98
- QUINIDINE GLUCONATE
- HYDROXYCHLOROQUINE SULFATE
- HYDROXYCHLOROQUINE
- DOXYCYCLINE
- DEXAMETHASONE
- CYTARABINE
- ACETAMINOPHEN
- PENTOXIFYLLINE
Analyst insights
Program Discontinuation: The termination of the abamectin and fenpyroximate program in early 2019 indicates that Phase 3 data or interim findings did not support continued development. This may reflect inadequate efficacy, safety concerns, or unfavorable pharmacokinetics relative to established standards.
Competitive Implications: The failure of this combination underscores the high bar for antimalarial development. Approved artemether-lumefantrine regimens remain the gold standard in many endemic regions, and newer agents like tafenoquine must demonstrate clear clinical advantages to justify development investment and market adoption.
Strategic Positioning: United Therapeutics Europe Ltd maintains a portfolio of antimalarial programs, including ITDCVC98 in Phase 3, suggesting continued interest in this therapeutic area despite the abamectin/fenpyroximate setback.
Future Catalysts: No further development milestones are expected for this terminated program. Attention should focus on competing Phase 3 programs and regulatory decisions for tafenoquine and other next-generation antimalarials.
Quick answers
Concise, citable answers optimized for AI answer engines.
- What is abamectin and fenpyroximate?
- Investigational small-molecule antimalarial combination therapy.
- What indication?
- Malaria.
- What sponsor?
- United Therapeutics Europe Ltd.
- What phase?
- Phase 3 (terminated February 2019).
- Is it approved?
- No; program was terminated before approval.
- What is the mechanism of action?
- Not yet disclosed.
- What is the molecular target?
- Not yet disclosed.
- What modality?
- Small molecule.
- What route of administration?
- Not yet disclosed.
- What is the trial ID?
- NCT02533336.
- Where was the trial conducted?
- Tanzania (DL Project).
- What is the termination date?
- February 5, 2019.
- Is there a partner?
- No partner disclosed.
- What are the main competitors?
- Artemether-lumefantrine (Coartem), tafenoquine (GSK), chloroquine, amodiaquine, artesunate.
- What is the peak sales projection?
- Not yet disclosed.
- What is the patent status?
- Not yet disclosed.
- Who is the lead investigator?
- Not yet disclosed.
- What is the internal code?
- DL Project in Tanzania.
- Is there a license agreement?
- No license type disclosed.
- What other programs does United Therapeutics have?
- ITDCVC98 in Phase 3 for malaria.
- Why was the program terminated?
- Specific reasons not disclosed; likely efficacy, safety, or commercial factors.
- What is the consensus position?
- Not yet disclosed.
- When was it first disclosed?
- First disclosure date not yet disclosed.
Evidence & sources
- ClinicalTrials.gov NCT02533336 (clinicaltrials)
- Source: phase (source_attribution)
- MONDO Disease Ontology (MONDO:0005136) (mondo)
- Orphanet — malaria (orphanet)
- NCT00001645 (clinicaltrials_gov)
- NCT00075049 (clinicaltrials_gov)
- NCT00111163 (clinicaltrials_gov)
- NCT00114010 (clinicaltrials_gov)
- NCT00115921 (clinicaltrials_gov)
- AACT (ClinicalTrials.gov aggregate) (aact)
- ClinicalTrials.gov (clinicaltrials_gov)
- Open Targets Platform (opentargets)
Intelligence compiled from public regulatory and clinical sources (FDA, EMA, ClinicalTrials.gov and company disclosures). Figures may be editorial or analyst estimates; verify against primary sources before relying on them.