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Demser (metirosine)
Metrosine (Demser), marketed by Aton Pharma Vpna, is a preoperative preparation for pheochromocytoma that inhibits the enzyme tyrosine 3-monooxygenase, crucial for catecholamine production. Its key strength lies in its well-established mechanism and market presence, with a key composition patent expiring in 2028. The primary risk is the potential increase in competition post-patent expiry in 2028.
At a glance
| Generic name | metirosine |
|---|---|
| Sponsor | Aton Pharma Vpna |
| Drug class | Catecholamine Synthesis Inhibitor [EPC] |
| Target | Tyrosine 3-monooxygenase |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1979 |
Approved indications
- Preoperative preparation for pheochromocytoma
- Management of inoperable pheochromocytoma
- Chronic treatment of malignant pheochromocytoma
Common side effects
- Sedation
- Diarrhea
- Extrapyramidal signs
- Anxiety and psychic disturbances
- Hematologic disorders
- Hypersensitivity reactions
- Crystalluria
- Transient dysuria and hematuria
- Impotence or failure of ejaculation
- Nasal stuffiness
- Decreased salivation
- Dry mouth
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:
- Demser CI brief — competitive landscape report
- Demser updates RSS · CI watch RSS
- Aton Pharma Vpna portfolio CI