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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
Phase 3 · small molecule · Malaria
GARSUN (artesunate) is an intravenous antiparasitic small molecule indicated for malaria, developed by United Therapeutics Europe Ltd. The program, internally coded ITDCVC98, comprises a portfolio of antimalarial agents including chloroquine, amodiaquine, primaquine, and artesunate. Artesunate, the lead asset, has comp
Internal code ITDCVC98
GARSUN (artesunate) is an intravenous antiparasitic small molecule indicated for malaria, developed by United Therapeutics Europe Ltd. The program, internally coded ITDCVC98, comprises a portfolio of antimalarial agents including chloroquine, amodiaquine, primaquine, and artesunate. Artesunate, the lead asset, has completed Phase 3 development with the latest milestone recorded on 12 January 2017. The compound has achieved regulatory approval in both the European Union and United States, with EMA authorization granted on 24 March 2026 under marketing authorization holders Amivas Ireland Ltd and B And O Pharm (EMA product numbers EMEA/H/C/005550 and EMEA/H/C/005718). In the US, artesunate received FDA approval under NDA213036 with AMIVAS as the sponsor. The intravenous formulation addresses severe malaria requiring parenteral therapy. United Therapeutics Europe Ltd operates within a competitive landscape that includes approved artemisinin-based combination therapies such as Coartem (artemether-lumefantrine) and EURARTESIM, as well as other antimalarial monotherapies. The program represents a strategic portfolio approach to malaria treatment across multiple drug classes and mechanisms.
Malaria remains a significant global health burden, particularly in sub-Saharan Africa and Southeast Asia, where drug-resistant parasites have emerged. Intravenous artesunate addresses a critical unmet need in severe malaria management, where rapid parasite clearance and mortality reduction are essential. The WHO recommends artesunate as the first-line treatment for severe malaria due to superior efficacy compared to quinine. The regulatory approval of GARSUN in both EU and US markets expands treatment options for healthcare systems managing severe malaria cases, particularly in referral hospitals and critical care settings. The competitive landscape includes artemisinin-based combinations and traditional antimalarials, but intravenous artesunate occupies a distinct niche for acute, severe disease requiring parenteral administration. United Therapeutics Europe Ltd's portfolio approach—combining artesunate with chloroquine, amodiaquine, and primaquine—suggests a strategy to address different malaria transmission scenarios and patient populations. The market relevance is substantial given the endemic burden in tropical and subtropical regions, the emergence of drug resistance, and the critical role of parenteral therapy in severe malaria management. Regulatory approval in major markets validates the clinical and safety profile, facilitating access in both developed healthcare systems and resource-limited endemic regions through international procurement mechanisms.
Drug Class: Antiparasitic products (P01); artemisinin derivative.
Modality: Small molecule.
Route of Administration: Intravenous.
Brand Name: GARSUN.
International Nonproprietary Name (INN): Artesunate.
Mechanism of Action: Not yet disclosed in available documentation.
Molecular Target: Not yet disclosed in available documentation.
Related Therapies: The program encompasses a portfolio including chloroquine (4-aminoquinoline), amodiaquine (4-aminoquinoline derivative), primaquine (8-aminoquinoline), and artesunate (artemisinin derivative). Artesunate is frequently combined with partner drugs in artemisinin-based combination therapies (ACTs) for uncomplicated malaria, though the IV formulation is reserved for severe disease.
First Approval: EMA approval granted 24 March 2026; FDA approval status confirmed with NDA213036.
Patent Status: Not yet disclosed.
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).
Phase 3 completion
Latest disclosed milestone for the GARSUN program; Phase 3 development completed.
EMA approval
GARSUN (artesunate IV) approved by European Medicines Agency under EMEA/H/C/005550 and EMEA/H/C/005718.
FDA approval
GARSUN approved by US FDA under NDA213036 with AMIVAS as sponsor; specific approval date not yet disclosed.
The antimalarial market includes multiple approved therapies across different drug classes and formulations. EURARTESIM (artesunate-amodiaquine combination) represents a direct competitor in the artemisinin-based combination therapy space, though formulated for oral administration in uncomplicated malaria. Coartem (artemether-lumefantrine combination) and related artemether-lumefantrine formulations, also marketed by United Therapeutics Europe Ltd, address uncomplicated malaria but via different artemisinin derivatives and partner agents. Traditional monotherapies including chloroquine, amodiaquine, sulfadoxine-pyrimethamine, and primaquine remain in use, though resistance patterns vary by region. Tafenoquine (GlaxoSmithKline, Phase 3) represents an emerging competitor in the 8-aminoquinoline class for malaria prevention and treatment. GARSUN's intravenous formulation occupies a distinct clinical niche for severe malaria requiring parenteral therapy, differentiating it from oral combination therapies. The competitive positioning reflects United Therapeutics Europe Ltd's portfolio strategy, which encompasses multiple drug classes and formulations to address different malaria transmission scenarios and disease severity levels. Regulatory approval in both EU and US markets provides GARSUN with market access advantages in developed healthcare systems, while WHO prequalification status (if obtained) would facilitate procurement in endemic regions.
| Therapy | Company | Mechanism | Status |
|---|---|---|---|
| EURARTESIM | — | — | approved |
| AL (Coartem) | 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 |
| Chloroquine | 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 |
| primaquine | Repatha | small_molecule | approved |
| Amodiaquine plus Artesunate co-administration | United Therapeutics Europe Ltd | small_molecule | approved |
| Artesunate-amodiaquine combination | United Therapeutics Europe Ltd | small_molecule | approved |
| abamectin and fenpyroximate | United Therapeutics Europe Ltd | small_molecule | phase_3 |
| Tafenoquine | GlaxoSmithKline | 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.
European Union: GARSUN (artesunate IV) approved by the European Medicines Agency on 24 March 2026. Marketing authorization holders: Amivas Ireland Ltd and B And O Pharm. EMA product numbers: EMEA/H/C/005550 and EMEA/H/C/005718. Evidence available at https://www.ema.europa.eu/en/medicines/human/EPAR/garsun.
United States: GARSUN approved by the FDA. Sponsor: AMIVAS. Application number: NDA213036. Evidence available via FDA drug database at https://open.fda.gov/apis/drug/drugsfda/. Specific approval date not yet disclosed.
Japan (PMDA): Regulatory status not yet disclosed.
China (NMPA): Regulatory status not yet disclosed.
WHO Prequalification: Status not yet disclosed.
GARSUN (artesunate) is an intravenous antimalarial indicated for malaria, specifically severe malaria requiring parenteral therapy.
Yes, GARSUN received FDA approval under NDA213036 with AMIVAS as the sponsor. The specific approval date has not been disclosed.
Yes, GARSUN was approved by the European Medicines Agency on 24 March 2026 under marketing authorization holders Amivas Ireland Ltd and B And O Pharm.
Marketing authorization holders in the EU are Amivas Ireland Ltd and B And O Pharm. The US sponsor is AMIVAS.
GARSUN is administered intravenously, making it suitable for severe malaria cases requiring parenteral therapy.
The specific mechanism of action is not yet disclosed in available documentation.
GARSUN was developed by United Therapeutics Europe Ltd under the internal code ITDCVC98.
The program is supported by NCT00158548, a Phase 3 trial. Detailed trial results have not been disclosed.
GARSUN is classified as an antiparasitic product (P01), specifically an artemisinin derivative.
Competitors include EURARTESIM (artemisinin-based combination), Coartem (artemether-lumefantrine), and other antimalarials such as chloroquine, amodiaquine, and emerging agents like tafenoquine.
WHO prequalification status has not been disclosed.
GARSUN has completed Phase 3 development (as of January 2017) and has achieved regulatory approval in the EU and US.
No partner is listed for this program; development has been conducted by United Therapeutics Europe Ltd.
GARSUN has two EMA product numbers: EMEA/H/C/005550 and EMEA/H/C/005718.
The FDA application number for GARSUN is NDA213036.
Generic artesunate formulations exist; GARSUN is the branded intravenous formulation by United Therapeutics Europe Ltd.
ITDCVC98 → Drug → Target → Indication → Company → Trials → Competitors
Strategic Positioning: United Therapeutics Europe Ltd's portfolio approach—combining intravenous artesunate with oral antimalarials (chloroquine, amodiaquine, primaquine)—reflects a comprehensive strategy addressing severe and uncomplicated malaria across different transmission settings. The completion of Phase 3 development by January 2017 and subsequent regulatory approvals in EU (2026) and US markets demonstrate a multi-year development and approval trajectory.
Competitive Implications: GARSUN's intravenous formulation occupies a distinct clinical niche for severe malaria, differentiating it from oral artemisinin-based combinations like EURARTESIM and Coartem. However, the competitive landscape includes established artemisinin derivatives and emerging agents like tafenoquine. Market penetration will depend on clinical adoption, pricing, and WHO prequalification status for endemic-region procurement.
Regulatory Catalysts: Future milestones include potential WHO prequalification, label expansions for pediatric or pregnancy indications, and geographic regulatory approvals in endemic regions (Africa, Southeast Asia). Pharmacovigilance data post-approval may inform safety communications or label updates.
Commercial Considerations: Peak sales projections not yet disclosed. Market size depends on severe malaria incidence, healthcare system adoption in developed markets, and procurement volume in endemic regions. Pricing strategy relative to generic artesunate formulations and competitor products will influence market share.
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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.