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Daruma (IDEBENONE)
Idenbenone (Daruma) is a marketed drug primarily indicated for Leber's optic atrophy, leveraging its mechanism of increasing coenzyme Q10 levels to protect the optic nerve. A key strength of Daruma is its unique mechanism of action, which differentiates it from competitors such as abiraterone acetate, aliskiren, alprazolam, amiodarone, and amprenavir, all of which target different mechanisms despite some overlap. The primary risk for Daruma is the expiration of its key composition patent in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | IDEBENONE |
|---|---|
| Drug class | idebenone |
| Target | Cytochrome P450 2C19 |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
| First approval | 2015 |
Approved indications
- Leber's optic atrophy
Common side effects
Key clinical trials
- Study of Oral Idebenone to Treat Non-Alcoholic Steatohepatitis (PHASE1,PHASE2)
- Genetic and Physical Study of Childhood Nerve and Muscle Disorders
- A Clinical Study of the Efficacy of Idebenone in the Treatment of iRBD Into Synucleinopathies (PHASE2)
- ROAR-DIGAP: A Widely Inclusive, Largely Virtual Pilot Trial Utilizing DIGAP (Deep Integrated Genomics Analysis Platform) To Personalize Treatments (PHASE2)
- Idebenone for the Preventive Treatment of Migraine (PHASE3)
- A Study of Efficacy and Safety of Idebenone Vs. Placebo in Prodromal Parkinson Disease (PHASE2,PHASE3)
- Exploring the Preventive Effect of Mitochondrial Protective Agent Idebenone on Post-stroke Epilepsy (PHASE4)
- Study to Assess the Efficacy, Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia (PHASE3)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Daruma CI brief — competitive landscape report
- Daruma updates RSS · CI watch RSS