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METYROSINE
Metyrosine is a marketed drug primarily indicated for preoperative preparation, with a key composition patent expiring in 2028. Its primary strength lies in its established use and market presence for preoperative preparation. The primary risk is the potential increase in competition following the patent expiry in 2028.
At a glance
| Generic name | METYROSINE |
|---|---|
| Drug class | Catecholamine Synthesis Inhibitor [EPC] |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1979 |
Approved indications
- Preoperative preparation
- Management when surgery is contraindicated
- Chronic treatment of malignant pheochromocytoma
Common side effects
- Sedation
- Extrapyramidal signs (drooling, speech difficulty, tremor)
- Diarrhea
- Anxiety and psychic disturbances (depression, hallucinations, disorientation, confusion)
- Insomnia
- Fatigue
- Nausea
- Vomiting
- Headache
- Dry mouth
- Decreased salivation
- Nasal stuffiness
Serious adverse events
- Parkinsonism
- Trismus
- Crystalluria
- Hematuria
- Thrombocytopenia
- Anemia
- Pharyngeal edema
- Hypersensitivity reactions
Drug interactions
- phenothiazines
- haloperidol
- alcohol
- other CNS depressants
Key clinical trials
- SM-88 Maintenance Therapy for Advanced Ewing's Sarcoma and as Salvage Therapy for Sarcoma (PHASE2)
- A Randomized Phase 2/3 Multi-Center Study of SM-88 in Participants With Metastatic Pancreatic Cancer (PHASE2, PHASE3)
- Safety of L1-79 in Adolescent and Adult Males With Autism (PHASE2)
- A 12-Week Crossover Study to Assess the Efficacy, Safety and Tolerability of L1-79 in Subjects Aged 12-21 Years With Autism Spectrum Disorder (PHASE2)
- Oral SM-88 in Patients With Metastatic HR+/HER2- Breast Cancer (PHASE2)
- Understanding Dopamine Mechanisms in Cocaine Addiction Using AMPT and Methylphenidate With [11C]RAC/[11C]PHNO PET (NA)
- Study of SM-88 in Advanced Cancers (PHASE1, PHASE2)
- Intraoperative Carbetocin to Decrease Blood Loss During Hysteroscopic Myomectomy (PHASE4)
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:
- METYROSINE CI brief — competitive landscape report
- METYROSINE updates RSS · CI watch RSS