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AMX0035 — Competitive Intelligence Brief

AMX0035 (AMX0035) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Neuroprotective agent; combination therapy. Area: Neurology.

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)

Auto-detected by same drug class / molecular target / therapeutic area, ranked by phase + recency. Override with ?vs=slug1,slug2,….

DrugGenericSponsorPhaseClassTargetApproval / 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)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Neuroprotective agent; combination therapy class)

  1. 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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