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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
Approved · small molecule · Malaria
Coartem (artemether-lumefantrine) is an oral small-molecule antimalarial combination therapy approved for the treatment of malaria. The program is sponsored by United Therapeutics Europe Ltd under internal code 20/CNBS/22. Artemether, the artemisinin-derived component, is the active pharmaceutical ingredient tracked in
Internal code 20/CNBS/22
Coartem (artemether-lumefantrine) is an oral small-molecule antimalarial combination therapy approved for the treatment of malaria. The program is sponsored by United Therapeutics Europe Ltd under internal code 20/CNBS/22. Artemether, the artemisinin-derived component, is the active pharmaceutical ingredient tracked in this profile, with the brand name Coartem and oral route of administration. The drug has achieved approved regulatory status and is listed under FDA application number NDA022268, with original sponsorship by Novartis. The latest milestone was recorded on 2025-08-27, indicating ongoing program activity. As an established antimalarial therapy, Coartem represents a key treatment option within the global malaria therapeutic landscape, competing against multiple other antimalarial regimens including chloroquine, sulfadoxine-pyrimethamine, artesunate-amodiaquine combinations, and newer agents such as tafenoquine. The program's current status is completed, suggesting that development activities have concluded and the therapy is in commercial or post-approval phase.
Malaria remains a significant global health burden, particularly in sub-Saharan Africa and other endemic regions, necessitating effective, accessible treatment options. Coartem addresses this unmet need as a combination antimalarial with a well-established safety and efficacy profile. The therapy is positioned within a competitive landscape that includes both older antimalarials (chloroquine, sulfadoxine-pyrimethamine) and newer agents (artesunate-amodiaquine combinations, tafenoquine). As an artemisinin-based combination therapy (ACT), Coartem represents a standard-of-care approach recommended by the World Health Organization for uncomplicated malaria treatment in many endemic regions.
The patient population encompasses millions of individuals in malaria-endemic countries, with particular relevance in pediatric and adult populations across Africa, Asia, and Latin America. Commercial significance is substantial given the endemic nature of malaria and the ongoing demand for effective, affordable treatments. United Therapeutics Europe Ltd's sponsorship of this program suggests strategic focus on antimalarial therapeutics as part of a broader portfolio addressing infectious diseases and neglected tropical diseases. The competitive positioning of Coartem is strengthened by its oral formulation, combination approach to reduce resistance development, and established regulatory approval, though it faces competition from multiple alternative regimens and emerging therapies.
Drug Class: Artemisinin-based combination antimalarial
Active Pharmaceutical Ingredient: Artemether (component of Coartem combination)
Modality: Small-molecule
Route of Administration: Oral
Mechanism of Action: Not yet disclosed in available facts
Target: Not yet disclosed in available facts
Related Therapies: Artemether-lumefantrine combinations, artesunate-amodiaquine combinations, chloroquine, sulfadoxine-pyrimethamine, primaquine, tafenoquine
First Approval: FDA approval documented under NDA022268 with Novartis as original sponsor
Patent Status: Not yet disclosed in available facts
Prevalence: Point prevalence: 1-9 / 100 000 (Europe) — source: Orphanet, validated.
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.
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:
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).
Latest program milestone recorded
Most recent activity documented for the Coartem program under United Therapeutics Europe Ltd sponsorship.
Coartem operates within a crowded antimalarial therapeutic landscape dominated by multiple approved and investigational agents. Direct competitors include artemether-lumefantrine formulations from Avenue Therapeutics Inc. and United Therapeutics Europe Ltd itself, indicating potential market segmentation or regional differentiation strategies. Older antimalarials such as chloroquine and sulfadoxine-pyrimethamine remain approved and in use despite emerging resistance concerns. Artesunate-amodiaquine combinations represent alternative artemisinin-based approaches with similar therapeutic positioning. Emerging competitors include tafenoquine (GlaxoSmithKline, phase 3 status), which may offer differentiated pharmacokinetics or dosing convenience. The competitive data provided lists multiple agents under United Therapeutics Europe Ltd sponsorship, suggesting either a comprehensive portfolio approach or potential data classification issues. Primaquine (listed under Repatha company attribution, likely a data error) remains a standard hypnozoitocidal agent for P. vivax and P. ovale malaria. Overall, Coartem's competitive position is established through regulatory approval and clinical use, though ongoing competition from alternative combinations and newer agents continues to evolve the treatment landscape.
| Therapy | Company | Mechanism | Status |
|---|---|---|---|
| Amodiaquine plus Artesunate co-administration | United Therapeutics Europe Ltd | small_molecule | approved |
| Chloroquine | United Therapeutics Europe Ltd | small_molecule | approved |
| artemether lumefantrine | 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 |
| artemether-lumefantrine (ALN) | United Therapeutics Europe Ltd | small_molecule | approved |
| abamectin and fenpyroximate | United Therapeutics Europe Ltd | small_molecule | phase_3 |
| SP, chloroquine, amodiaquine, primaquine, artesunate | United Therapeutics Europe Ltd | small_molecule | phase_3 |
| Tafenoquine | GlaxoSmithKline | small_molecule | phase_3 |
| Artemether-lumefantrine | AVENUE THERAPEUTICS, INC. | 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.
United States (FDA): Artemether component approved under NDA022268 with Novartis as original sponsor. Current sponsor listed as United Therapeutics Europe Ltd.
European Medicines Agency (EMA): Not yet disclosed in available facts
Japan (PMDA): Not yet disclosed in available facts
China (NMPA): Not yet disclosed in available facts
Regulatory Status Summary: Approved small-molecule antimalarial with established FDA regulatory history. Specific approval dates, marketing authorizations in other jurisdictions, and post-approval regulatory activities are not yet disclosed in available facts.
Coartem is an oral antimalarial combination therapy used for the treatment of malaria, containing artemether as the active pharmaceutical ingredient.
Yes, Coartem is FDA-approved under application number NDA022268, originally sponsored by Novartis and now under United Therapeutics Europe Ltd sponsorship.
The mechanism of action is not yet disclosed in available facts, though artemether is an artemisinin-derived antimalarial component of the combination therapy.
Coartem is currently sponsored by United Therapeutics Europe Ltd; original FDA approval was under Novartis sponsorship.
Coartem is administered orally.
NCT05343312 is associated with the Coartem program; detailed trial objectives, design, and results are not yet disclosed in available facts.
Artemether is the tracked active pharmaceutical ingredient in Coartem, which is formulated as a combination antimalarial therapy.
Competitors include artesunate-amodiaquine combinations, chloroquine, sulfadoxine-pyrimethamine, primaquine, tafenoquine (GlaxoSmithKline), and other artemether-lumefantrine formulations.
European Medicines Agency approval status is not yet disclosed in available facts.
Coartem program status is marked as completed and approved, with the latest milestone recorded on 2025-08-27.
The internal program code is 20/CNBS/22 under United Therapeutics Europe Ltd sponsorship.
Yes, tafenoquine (GlaxoSmithKline) is in phase 3 development and represents an emerging competitive option with potentially differentiated pharmacokinetics.
Therapeutic class is not yet disclosed in available facts, though Coartem is classified as an artemisinin-based combination antimalarial.
Yes, Coartem is an artemether-lumefantrine combination therapy designed to provide synergistic antimalarial activity and reduce resistance development.
Coartem is used for malaria treatment across endemic regions, with particular relevance in pediatric and adult populations in Africa, Asia, and Latin America.
Regulatory status in Japan (PMDA) and China (NMPA) is not yet disclosed in available facts.
AL (Coartem) → Drug → Target → Indication → Company → Trials → Competitors
Strategic Positioning: United Therapeutics Europe Ltd's sponsorship of the Coartem program suggests continued investment in established antimalarial therapies alongside potential development of novel agents. The transition of sponsorship from Novartis to United Therapeutics Europe Ltd may indicate portfolio acquisition, licensing, or regional market focus strategies.
Competitive Implications: Coartem maintains competitive relevance through regulatory approval and established clinical use, yet faces pressure from emerging alternatives including tafenoquine and novel combination approaches. The presence of multiple artemether-lumefantrine formulations in the competitive landscape suggests market fragmentation or regional differentiation.
Development Status: Program status marked as 'completed' with latest milestone in August 2025 indicates post-approval phase activity. The presence of NCT05343312 suggests ongoing clinical research, potentially post-marketing surveillance, comparative effectiveness studies, or additional indication exploration.
Future Catalysts: Potential catalysts include regulatory approvals in additional jurisdictions (EMA, PMDA, NMPA), label expansions to additional malaria species or patient populations, combination studies with novel agents, and real-world effectiveness data publication. Competitive threats from tafenoquine and other emerging therapies may drive differentiation strategies.
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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.