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Xelstrym (dexamfetamine)
Xelstrym works by blocking the reuptake of noradrenaline, allowing it to stay in the brain for longer and increasing alertness and focus.
At a glance
| Generic name | dexamfetamine |
|---|---|
| Sponsor | UCB |
| Drug class | Central Nervous System Stimulant [EPC] |
| Target | Sodium-dependent noradrenaline transporter |
| Therapeutic area | Nephrology |
| Phase | FDA-approved |
| First approval | 1955 |
| Annual revenue | 172 |
Mechanism of action
Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The exact mode of therapeutic action in ADHD is not known.
Approved indications
- Attention deficit hyperactivity disorder
- Narcolepsy
Boxed warnings
- WARNING: ABUSE, MISUSE, AND ADDICTION XELSTRYM has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including XELSTRYM, can result in overdose and death [see OVERDOSAGE (10) ] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing XELSTRYM, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout XELSTRYM treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see WARNINGS AND PRECAUTIONS (5.1) and DRUG ABUSE AND DEPENDENCE (9.2) ] . WARNING: ABUSE, MISUSE, AND ADDICTION See full prescribing information for complete boxed warning. XELSTRYM has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including XELSTRYM, can result in overdose and death ( 5.1 , 9.2 , 10 ): Before prescribing XELSTRYM, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
Common side effects
- Palpitations
- Tachycardia
- Elevation of blood pressure
- Cardiomyopathy
- Psychotic episodes
- Overstimulation
- Restlessness
- Dizziness
- Insomnia
- Euphoria
- Dyskinesia
- Dysphoria
Drug interactions
- Ioflupane I-123
- isocarboxazid
- pargyline
- phenelzine
- tranylcypromine
Key clinical trials
- Efficacy and Safety of Sustained-release Dexamphetamine in Patients With Moderate to Severe Cocaine Use Disorder (PHASE2)
- A Trial to Assess How Centanafadine Interacts With Stimulants in the Body (PHASE1)
- Clinical Trial of High Dose Lisdexamfetamine and Contingency Management in MA Users (PHASE2)
- Pharmacological and Behavioral Treatment After Bariatric Surgery: Medication Change for Non-Responders (Stage 2b) (PHASE2,PHASE3)
- Clinical Trial to Investigate the Safety and Efficacy of Two Dexamfetamine Sulfate Formulations in Adults With ADHD and Moderate to Severe Depression (PHASE2)
- Vyvanse in Children Aged 6 to 12 Years (EARLY_PHASE1)
- Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Maintenance Treatment (PHASE3)
- Pharmacologic Augmentation of Targeted Cognitive Training in Schizophrenia (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 |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Xelstrym CI brief — competitive landscape report
- Xelstrym updates RSS · CI watch RSS
- UCB portfolio CI