Last reviewed · How we verify
Symlin (PRAMLINTIDE)
At a glance
| Generic name | PRAMLINTIDE |
|---|---|
| Sponsor | Astrazeneca Ab |
| Target | Amylin receptor AMY2, Amylin receptor AMY1, Amylin receptor AMY3 |
| Modality | Recombinant protein |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2005 |
Approved indications
- Type 1 Diabetes Mellitus Treatment Adjunct
- Type 2 Diabetes Mellitus Treatment Adjunct
Boxed warnings
- WARNING: SEVERE HYPOGLYCEMIA SYMLIN use with insulin increases the risk of severe hypoglycemia, particularly in patients with type 1 diabetes. When severe hypoglycemia occurs, it is seen within 3 hours following a SYMLIN injection. Serious injuries may occur if severe hypoglycemia occurs while operating a motor vehicle, heavy machinery, or while engaging in other high-risk activities. Appropriate patient selection, careful patient instruction, and insulin dose reduction are critical elements for reducing this risk. WARNING: SEVERE HYPOGLYCEMIA See full prescribing information for complete boxed warning. • SYMLIN use with insulin has been associated with an increased risk of severe hypoglycemia, particularly in patients with type 1 diabetes. • Hypoglycemia risk may be reduced by appropriate patient selection, careful patient instruction, and insulin dose reduction (5.1 , 5.2) .
Common side effects
- Nausea
- Anorexia
- Vomiting
- Headache
- Fatigue
- Arthralgia
- Dizziness
- Inflicted Injury
- Abdominal pain
- Cough
- Pharyngitis
- Severe Hypoglycemia
Key clinical trials
- Two Way Crossover Closed Loop Study Insulin vs Insulin and Pramlintide (NA)
- Amylin-Induced Migraine Attacks Without Aura (NA)
- Hypersensitivity to Amylin in Post-Traumatic Headache (NA)
- Multi-Center Development of a Novel Diagnostic Test for Alzheimer's Disease (EARLY_PHASE1)
- Tailoring Obesity Treatment Trial (PHASE2, PHASE3)
- A Fully Automated Lyumjev and Pramlintide Delivery System for Adults With Type 1 Diabetes (PHASE2, PHASE3)
- Phase 2, Randomized, Open-Label, Crossover, PD/PK Study of a Novel Pram-Insulin Co-Formulation in Adults With T1D (PHASE2)
- The Role of Amylin in Bone Metabolism (NA)
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:
- Symlin CI brief — competitive landscape report
- Symlin updates RSS · CI watch RSS