Malaria Product Launch Dashboard
Tracking new antimalarial medicines along the market access pathway
Target use case
Triple artemisinin-based combination therapy in clinical development. Its potential future role may include use within treatment-diversification or MFT strategies, subject to clinical results, regulatory assessment, WHO recommendations and country decisions.
Access & supply commitments
- Fixed-dose combination developed and made by Fosun Pharma. Pivotal trial (FD-TACT) run by MORU/University of Oxford with MMV and Marubeni, funded by the GHIT Fund.
- Fosun Pharma has committed to make it "accessible and affordable for malaria-endemic countries". No price published.
- Paediatric dispersible tablet (20/120/40 mg) being tested in FD-TACT.
Adoption requirements
- Updated treatment guidelines and job aids
- Training on a new co-formulated product (same 6-dose, 3-day schedule as AL).
Country access
Operational research
Is fixed-dose ALAQ as effective as AL and ASAQ (28-day cure, FD-TACT), and safe? Adherence outside supervised treatment and use at scale are not yet studied.
Procurement through public channels
| Milestone | Status | Date achieved / submitted | Next expected step | Anticipated |
|---|---|---|---|---|
| Dose-optimization of co-formulationSource: Clin Pharmacol Ther: ALAQ dosing, 2025 | ✓ Complete | Published 2025 | — | — |
| Pivotal Phase III (FD-TACT)Source: ClinicalTrials.gov: FD-TACT trial | › In progress | First patient Sep 2025 | Results | 2026 |
| SRA/WLA submission | Not started | — | Dossier preparation | TBC |
| WHO PQ listingSource: WHO PQ: 24th malaria EOI invitation, 2025 · WHO: child malaria medicine priorities, 2025 | Not started | — | EOI listing, then dossier | TBC |
Target use case
WHO-recommended ACT with verified registration and adoption varying by country. LAUNCH is validating country-level registration, guideline inclusion, MFT positioning, procurement and routine-use information.
Access & supply commitments
- On the WHO list of prequalified medicines (tablets and granules), through the EMA EU-M4all (Article 58) route.
- Registration confirmed in 14 national registers so far: Benin, Burkina Faso, Cameroon, DR Congo, Ethiopia, Kenya, Mozambique, Myanmar (2022 renewal list), Nigeria, Rwanda, Senegal, Tanzania, Viet Nam and Zambia.
- MMV and Shin Poong reported registration in 29 countries in Africa and Asia (November 2022). Manufacturer-reported; not checked against national registers.
- The PYRAPREG trial protocol (BMJ Open, 2023) reports the tablets registered in 19 African and 5 Asian countries, and the granules in 15 African countries. Not checked against national registers.
- Co-developed by Shin Poong and MMV.
Adoption requirements
- Guideline inclusion and case-management training
- No cold chain (store below 30°C). Once daily for 3 days, with or without food. Not for people with liver disease.
Country access
A country can count at more than one stage.
Operational research
MFT deployment models with artesunate–pyronaridine
Procurement through public channels
Procurement figures are being reviewed and will be added later.
Presentations bought through Global Fund-financed orders
| Presentation | Pack |
|---|---|
| 20/60 mg granules | 90 sachets |
| 60/180 mg tablets | pack of 90 |
Orders paid for by other donors, national governments or private buyers are not included.
Target use case
WHO-recommended ACT used for treatment in a range of settings and potentially relevant to MFT strategies. Chemoprevention and mass drug administration are separate uses, each with its own indications, formulations, evidence and policy pathway.
Access & supply commitments
- Nine WHO-prequalified presentations from three companies: Alfasigma (2), Guilin (6, including 3 dispersible) and Beijing Holley (1).
- Registration confirmed in 20 national registers so far: Benin, Burkina Faso, Cameroon, Côte d'Ivoire, DR Congo, Ethiopia, Indonesia, Kenya, Mozambique, Myanmar (2022 renewal list), Namibia, Nigeria, Rwanda, Senegal, Tanzania, Thailand, The Gambia, Viet Nam, Zambia and Zimbabwe.
- Since July 2015 Eurartesim has been entrusted exclusively to Pierre Fabre in 32 African countries (Sigma-Tau, now Alfasigma). This is a commercial licence, not a registration.
Adoption requirements
- Prolongs the QT interval. Not for people with QT prolongation or on QT-prolonging medicines (WHO; EU label). The EU label advises an ECG during treatment; WHO says one is not needed before prescribing.
- Standard ACT training, plus food timing and the QT contraindications.
Country access
A country can count at more than one stage.
Operational research
MFT deployment (simultaneous, cycling or rotation) and resistance impact
Procurement through public channels
Procurement figures are being reviewed and will be added later.
Presentations bought through Global Fund-financed orders
| Presentation | Pack |
|---|---|
| 20/160 mg dispersible tablets | blister of 3 |
| 20/160 mg dispersible tablets | box of 2 blisters of 3 |
| 20/160 mg dispersible tablets | box of 25 blisters of 3 |
| 20/160 mg tablets | blister of 3 |
| 40/320 mg dispersible tablets | blister of 3 |
| 40/320 mg dispersible tablets | box of 2 blisters of 3 |
| 40/320 mg dispersible tablets | box of 25 blisters of 3 |
| 40/320 mg tablets | blister of 3 |
| 40/320 mg tablets | blister of 6 |
| 40/320 mg tablets | blister of 9 |
| 40/320 mg tablets | box of 25 blisters of 9 |
| 40/320 mg tablets | recorded as 3 per course, in a blister of 8 |
Orders paid for by other donors, national governments or private buyers are not included.
Target use case
Non-artemisinin combination in late-stage development. Novartis presents it as having the potential to combat antimalarial drug resistance; LAUNCH tracks it as a candidate for settings with artemisinin partial resistance and for multiple first-line therapy (MFT) strategies.
Access & supply commitments
- Price not public. MMV has said it will be supplied on a "largely not-for-profit" basis in low- and middle-income countries (reported Nov 2025).
- In Phase III: granules in a sachet, once daily for 3 days with a light meal, for adults and children ≥10 kg. Final product presentation subject to approval.
Adoption requirements
- New chemical class (imidazolopiperazine). Safety monitoring after approval will need planning (LAUNCH assessment).
- Health-worker training on new regimen
Country access
Operational research
Does it cure infections carrying artemisinin partial-resistance (kelch13) mutations as well as other infections? (KALUMA subgroup not yet published.) Does faster gametocyte clearance reduce infection of mosquitoes? (Not yet measured.)
Procurement through public channels
Acknowledgement
Developed by Novartis with the scientific and financial support of MMV, and within the framework of the WANECAM2 consortium, funded by the European & Developing Countries Clinical Trials Partnership Programme supported by the European Union, with co-funding from the German Aerospace Center and the UK Department of Health and Social Care.
| Milestone | Status | Date achieved / submitted | Next expected step | Anticipated |
|---|---|---|---|---|
| Phase III (KALUMA)Source: Novartis: GanLum Phase III results · MMV: GanLum Phase III results, 2025 · ClinicalTrials.gov: KALUMA trial | ✓ Complete | 12 Nov 2025 (trial completed 25 Nov 2025) | — | — |
| SRA dossier submissionSource: Novartis: GanLum Phase III results · MMV: GanLum Phase III results, 2025 | › In preparation | — | Submission | TBC |
| WHO GDG engagementSource: WHO: child malaria medicine priorities, 2025 | Not started | — | Pre-submission dialogue | TBC |
| WHO PQ listingSource: WHO PQ: 24th malaria EOI invitation, 2025 | Not started | — | EOI listing (not on 24th malaria EOI, Feb 2026) | TBC |
Country access map
Countries where a national medicines register confirms the medicine is registered. Choose another access stage under Filters; a country can appear at more than one stage.
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