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Relyvrio (TAURURSODIOL)
Relyvrio works by inhibiting the enzyme phospholipase A2, which is involved in the breakdown of lipids in the brain.
Relyvrio (taurursodiol) is a small molecule modality developed by AMYLYX, targeting phospholipase A2, and approved by the FDA in 2022 for the treatment of Amyotrophic lateral sclerosis (ALS). It is a patented medication with unknown half-life and bioavailability. Relyvrio's commercial status is proprietary, and its generic manufacturers are not yet established. Key safety considerations are not specified. Relyvrio is a treatment option for patients with ALS.
At a glance
| Generic name | TAURURSODIOL |
|---|---|
| Sponsor | Amylyx |
| Target | Phospholipase A2 |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2022 |
Mechanism of action
The mechanism by which RELYVRIO exerts its therapeutic effects in patients with ALS is unknown.
Approved indications
- Amyotrophic lateral sclerosis
Common side effects
Key clinical trials
- Monitoring of Early Disease Progression in Hereditary Transthyretin Amyloidosis
- TUDCA as a Therapy for Ulcerative Colitis (UC) (PHASE1)
- Integrative Liver-Targeted Therapy for Diabetic Macular Edema: Combining Tauroursodeoxycholate and Traditional Chinese Medicine. (PHASE2)
- Effect of Oral Supplement on Influenza Vaccine Long-term Response
- A Platform Trial for Personalized and Adaptive Therapies in Hepatocellular Carcinoma (PHASE2)
- Mitochondrial Capacity Boost in ALS (MICABO-ALS) Trial (PHASE2)
- Tauroursodeoxycholic Acid (TUDCA) Plus Camrelizumab and Regorafenib in Hepatocellular Carcinoma Previously Treated With Anti-PD1/PD-L1 and Bevacizumab (PHASE2)
- Open Label Extension Study of AMX0035 in Patients With ALS (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |