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AMX0035 — Competitive Intelligence Brief
phase 3
Neuroprotective agent; combination therapy
ER stress pathway, mitochondrial stability, neuroinflammation
Neurology
Small molecule
Live · refreshed every 30 min
Target snapshot
AMX0035 (AMX0035) — Amylyx Pharmaceuticals Inc.. AMX0035 is a fixed-dose combination of sodium phenylbutyrate and taurursodiol that reduces neuroinflammation and protects motor neurons by stabilizing mitochondrial function and reducing ER stress.
Comparator set (6 drugs)
| Drug | Generic | Sponsor | Phase | Class | Target | Approval / PDUFA |
|---|---|---|---|---|---|---|
| AMX0035 TARGET | AMX0035 | Amylyx Pharmaceuticals Inc. | phase 3 | Neuroprotective agent; combination therapy | ER stress pathway, mitochondrial stability, neuroinflammation | |
| NeuroAiD | NeuroAiD | CHIMES Society | marketed | Herbal neuroprotective agent | ||
| Butylphthalide Soft Capsules | Butylphthalide Soft Capsules | Peking Union Medical College Hospital | marketed | Neuroprotective agent | ||
| Xaliproden (SR57746A) | Xaliproden (SR57746A) | Sanofi | phase 3 | Neuroprotective agent | NMDA receptor | |
| Butylphthalide soft capsule | Butylphthalide soft capsule | Capital Medical University | phase 3 | Neuroprotective agent | Mitochondrial function modulator (non-specific) | |
| Edaravone Dexborneol Sequential Therapy | Edaravone Dexborneol Sequential Therapy | Simcere Pharmaceutical Co., Ltd | phase 3 | Neuroprotective agent combination | ||
| NXY-059 | NXY-059 | AstraZeneca | phase 3 | Free radical scavenger / Neuroprotective agent | Reactive oxygen species (ROS) / Free radicals |
Recent regulatory actions (last 90 days)
Upcoming PDUFA dates (next 180 days)
Patent timeline (forward window)
Sponsor landscape (Neuroprotective agent; combination therapy class)
- Amylyx Pharmaceuticals Inc. · 1 drug in this class
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Cite this brief
Drug Landscape (2026). AMX0035 — Competitive Intelligence Brief. https://druglandscape.com/ci/amx0035. Accessed 2026-05-13.
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