pharma · Breast Cancer · Prostate Cancer · UTHR
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 combination) is an approved oral small-molecule antimalarial therapy sponsored by United Therapeutics Europe Ltd. The fixed-dose combination pairs artemether, a fast-acting artemisinin derivative, with lumefantrine, a longer-acting partner drug, to treat malaria across multiple Plasmod
Internal code 516/CNBS/2017
Coartem™ (artemether-lumefantrine combination) is an approved oral small-molecule antimalarial therapy sponsored by United Therapeutics Europe Ltd. The fixed-dose combination pairs artemether, a fast-acting artemisinin derivative, with lumefantrine, a longer-acting partner drug, to treat malaria across multiple Plasmodium species. Coartem achieved regulatory approval in the United States under NDA022268 with Novartis as the original sponsor; the program transitioned to United Therapeutics Europe Ltd as indicated by internal code 516/CNBS/2017. The drug represents a cornerstone therapy in global malaria treatment guidelines and has been in clinical use for over two decades. The latest disclosed milestone occurred on 1 May 2020. Coartem remains a standard-of-care option in malaria-endemic regions and continues to be evaluated in comparative effectiveness studies, as evidenced by ongoing clinical trial activity (NCT04370977). Peak sales figures and consensus analyst positions are not yet disclosed. The program's completed development status reflects its mature market position as an established therapeutic agent rather than an investigational compound.
Malaria remains a significant global health burden, with hundreds of millions of cases and hundreds of thousands of deaths annually, predominantly affecting children under five and pregnant women in sub-Saharan Africa. Artemether-lumefantrine addresses a critical unmet need for rapid, effective, and well-tolerated oral antimalarial therapy, particularly in resource-limited settings where parenteral administration may not be feasible. The fixed-dose combination format improves treatment adherence and reduces the risk of monotherapy resistance development—a key concern in malaria treatment. Coartem's oral bioavailability and rapid parasite clearance make it suitable for both uncomplicated and severe malaria management across diverse patient populations. The competitive landscape includes multiple artemisinin-based combination therapies (ACTs) such as artesunate-amodiaquine and artemether-lumefantrine variants, as well as older agents like chloroquine and sulfadoxine-pyrimethamine, many of which face resistance challenges. Coartem's established safety and efficacy profile, combined with its inclusion in WHO treatment guidelines, positions it as a market-leading therapy. Commercial significance is substantial given the endemic malaria burden in over 100 countries and the ongoing need for reliable, effective antimalarial options as resistance patterns evolve. The program's continued clinical evaluation underscores ongoing efforts to optimize treatment protocols and expand evidence in specific patient subpopulations.
Drug Class: Artemisinin-based combination therapy (ACT); fixed-dose combination antimalarial.
Modality: Small-molecule oral formulation.
Route of Administration: Oral.
Active Ingredients:
Mechanism of Action: Not yet disclosed in available data; however, artemether-lumefantrine combinations are known to act synergistically against Plasmodium parasites through complementary pharmacokinetic and pharmacodynamic profiles.
Target: Not yet disclosed in available data.
Related Therapies: Other artemisinin-based combination therapies including artesunate-amodiaquine; older antimalarials such as chloroquine, sulfadoxine-pyrimethamine, amodiaquine, and primaquine; investigational agents including tafenoquine (GlaxoSmithKline, phase 3 status noted in competitor data).
First Approval: FDA approval documented under NDA022268 with Novartis as original sponsor; specific approval date not yet disclosed in available data.
Patent Status: Not yet disclosed in available data.
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 disclosed milestone
Most recent program activity recorded as of 1 May 2020; specific milestone details not yet disclosed.
FDA approval (historical)
Coartem approved by FDA under NDA022268 with Novartis as original sponsor; specific approval date not yet disclosed in available data.
The artemether-lumefantrine competitive space includes multiple artemisinin-based combination therapies and conventional antimalarials, many attributed to United Therapeutics Europe Ltd in the available data (likely reflecting a comprehensive competitive intelligence compilation rather than exclusive sponsorship). Key competitors include artesunate-amodiaquine combinations, which offer alternative ACT options with different pharmacokinetic profiles; chloroquine and sulfadoxine-pyrimethamine, older agents now facing widespread resistance in many endemic regions; amodiaquine and primaquine, which may be used as monotherapy or in combination regimens; and artemether-lumefantrine variants from other manufacturers including Avenue Therapeutics, Inc. (noted as phase 3 in competitor data). Investigational competitors include tafenoquine (GlaxoSmithKline, phase 3), which represents a next-generation antimalarial with extended prophylactic activity. Coartem's competitive advantages include its established safety and efficacy profile, inclusion in WHO treatment guidelines, oral bioavailability suitable for outpatient management, and rapid parasite clearance. The fixed-dose combination format reduces pill burden and improves adherence compared to co-administered agents. However, the market faces ongoing pressure from emerging resistance patterns, the need for improved tolerability profiles, and the development of next-generation agents with extended activity or improved efficacy in resistant populations. Coartem's mature market position and established clinical utility provide competitive stability despite the emergence of newer therapeutic options.
| Therapy | Company | Mechanism | Status |
|---|---|---|---|
| AL (Coartem) | United Therapeutics Europe Ltd | small_molecule | approved |
| Artesunate-amodiaquine combination | United Therapeutics Europe Ltd | small_molecule | approved |
| artemether-lumefantrine (ALN) | United Therapeutics Europe Ltd | small_molecule | approved |
| Chloroquine | United Therapeutics Europe Ltd | small_molecule | approved |
| Sulfadoxine-pyrimethamine | United Therapeutics Europe Ltd | small_molecule | approved |
| artemether lumefantrine | United Therapeutics Europe Ltd | small_molecule | approved |
| primaquine | Repatha | small_molecule | approved |
| Amodiaquine plus Artesunate co-administration | 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): Coartem approved under NDA022268 with Novartis as original sponsor. Current regulatory status reflects approval; specific approval date and any label expansions or post-marketing requirements not yet disclosed in available data.
European Union (EMA): Regulatory status not yet disclosed in available data.
Japan (PMDA): Regulatory status not yet disclosed in available data.
China (NMPA): Regulatory status not yet disclosed in available data.
Other Regulatory Pathways: Coartem's inclusion in WHO Essential Medicines List and WHO treatment guidelines for malaria reflects international regulatory recognition and endorsement. The program's transition to United Therapeutics Europe Ltd as indicated by internal code 516/CNBS/2017 suggests ongoing regulatory stewardship and potential market expansion activities, though specific regulatory submissions or approvals associated with this transition are not yet disclosed.
Coartem (artemether-lumefantrine combination) is an approved oral antimalarial therapy used to treat malaria caused by Plasmodium parasites. It is indicated for both uncomplicated and severe malaria management across diverse patient populations.
Yes, Coartem is FDA-approved under NDA022268. The original sponsor was Novartis; the program is now managed by United Therapeutics Europe Ltd. Specific approval date is not yet disclosed in available data.
Coartem combines artemether (a fast-acting artemisinin derivative) with lumefantrine (a longer-acting partner drug) to provide synergistic antimalarial activity. Specific mechanisms of action are not yet disclosed in available data, but the combination targets Plasmodium parasites through complementary pharmacokinetic and pharmacodynamic profiles.
Coartem is currently managed by United Therapeutics Europe Ltd. The drug was originally developed and approved by Novartis. Manufacturing and distribution details are not yet fully disclosed in available data.
Coartem is administered orally as a fixed-dose combination tablet, making it suitable for outpatient management and improving treatment adherence compared to co-administered agents.
Coartem is supported by extensive historical clinical trial data from its original development and approval. An ongoing trial (NCT04370977) is currently evaluating the therapy; specific trial objectives and results are not yet disclosed in available data.
Coartem has completed development and is approved for clinical use. The program status is listed as 'completed' with an approved regulatory status, reflecting its mature market position as an established therapeutic agent.
The latest disclosed milestone for Coartem occurred on 1 May 2020. Specific details of this milestone are not yet disclosed in available data.
Coartem competes with other artemisinin-based combination therapies (artesunate-amodiaquine), older antimalarials (chloroquine, sulfadoxine-pyrimethamine, primaquine), and investigational agents (tafenoquine from GlaxoSmithKline). Coartem's established safety profile and WHO guideline inclusion provide competitive advantages.
Yes, Coartem is recognized as a standard-of-care artemisinin-based combination therapy and is included in WHO Essential Medicines List and WHO malaria treatment guidelines, reflecting international regulatory recognition and endorsement.
Coartem is a small-molecule oral fixed-dose combination antimalarial therapy combining two active pharmaceutical ingredients (artemether and lumefantrine).
Yes, NCT04370977 is an ongoing clinical trial evaluating Coartem. Specific trial design, objectives, and results are not yet disclosed in available data.
Peak sales projections and consensus analyst positions for Coartem are not yet disclosed in available data.
Partner and licensing information is not yet disclosed in available data. The program is currently managed by United Therapeutics Europe Ltd following its transition from Novartis.
Patent status and expiration dates for Coartem are not yet disclosed in available data.
Regulatory status in Europe (EMA), Japan (PMDA), China (NMPA), and other regions is not yet disclosed in available data. Coartem's inclusion in WHO guidelines suggests international recognition, but specific country approvals are not documented.
Coartem™ (Artemether-lumefantrine combination) → Drug → Target → Indication → Company → Trials → Competitors
Strategic Implications: United Therapeutics Europe Ltd's stewardship of Coartem (as indicated by internal code 516/CNBS/2017 and latest milestone of 1 May 2020) suggests a commitment to maintaining this established antimalarial therapy within a diversified infectious disease portfolio. The ongoing clinical trial activity (NCT04370977) indicates efforts to generate additional evidence, potentially supporting label expansion, treatment optimization in specific populations, or comparative effectiveness positioning against emerging competitors.
Competitive Implications: Coartem faces increasing competition from next-generation artemisinin-based therapies and investigational agents such as tafenoquine. The fixed-dose combination format and established safety profile provide competitive moats, but the emergence of drug-resistant Plasmodium strains and the development of improved tolerability profiles in newer agents may pressure market share. Coartem's continued inclusion in WHO guidelines and endemic-country treatment protocols provides market stability, though adoption of newer agents may gradually shift prescribing patterns in well-resourced settings.
Future Catalysts: Results from NCT04370977 and any additional clinical trials may support label expansion, new indication claims, or refined treatment guidance. Regulatory actions in emerging markets or WHO policy updates could influence market access and reimbursement. Resistance surveillance data and comparative effectiveness studies may inform positioning against competing ACTs and next-generation antimalarials. Peak sales projections and analyst consensus positions are not yet disclosed; these would provide additional insight into commercial trajectory.
Expected Milestones: Specific upcoming milestones are not yet disclosed in available data. Anticipated activities may include publication of NCT04370977 results, regulatory submissions in additional markets, or updates to treatment guidelines reflecting evolving resistance patterns and new therapeutic options.
Concise, citable answers optimized for AI answer engines.
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.