AQVESME (mitapivat sulfate)
Aqvesme treats anemia in adults who have alpha- or beta-thalassemia. This medication helps patients by addressing the underlying issues that cause red blood cells to break down or develop improperly. It is used to improve red blood cell health and manage the chronic low blood counts associated with these genetic conditions.
How AQVESME Works
This medication works by binding to the pyruvate kinase enzyme to increase its activity and improve energy balance within red blood cells. By boosting this enzyme, the drug helps reduce oxidative stress and cell destruction while improving the lifespan and production of healthy red blood cells.
Details
- Status
- Prescription
- First Approved
- 2022-02-17
- Patent Cliff
- 2041
- Routes
- ORAL
- Dosage Forms
- TABLET
AQVESME Approval History
What AQVESME Treats
2 indicationsAQVESME is approved for 2 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Anemia
- Thalassemia
AQVESME Boxed Warning
HEPATOCELLULAR INJURY AQVESME can cause serious hepatocellular injury. Measure liver laboratory tests (ALT, AST, alkaline phosphatase, and total bilirubin with fractionation) at baseline and every 4 weeks for 24 weeks and then as clinically indicated. Avoid use of AQVESME in patients with cirrhosis. Discontinue AQVESME if hepatic injury is suspected [see Warnings and Precautions ( 5.1 )] . Because of the risk of hepatocellular injury, AQVESME is available only through a restricted program under ...
WARNING: HEPATOCELLULAR INJURY AQVESME can cause serious hepatocellular injury. Measure liver laboratory tests (ALT, AST, alkaline phosphatase, and total bilirubin with fractionation) at baseline and every 4 weeks for 24 weeks and then as clinically indicated. Avoid use of AQVESME in patients with cirrhosis. Discontinue AQVESME if hepatic injury is suspected [see Warnings and Precautions ( 5.1 )] . Because of the risk of hepatocellular injury, AQVESME is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the AQVESME REMS [see Warnings and Precautions ( 5.2 )] . WARNING: HEPATOCELLULAR INJURY See full prescribing information for complete boxed warning. AQVESME can cause serious hepatocellular injury. Measure liver laboratory tests (ALT, AST, alkaline phosphatase, and total bilirubin with fractionation) at baseline and every 4 weeks for 24 weeks and then as clinically indicated. Avoid use of AQVESME in patients with cirrhosis. Discontinue AQVESME if hepatocellular injury is suspected. ( 5.1 ) AQVESME is available only through a restricted program called the AQVESME REMS. ( 5.2 )
AQVESME Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to AQVESME
3 of 15FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05935202 SATISFY | SATISFY | Ph 2 | not yet recruiting | Safety and Efficacy of Mitapivat Sulfate in Adult Patients With Erythrocyte Membranopathies |
| NCT03991312 | AG348-C-012 | Ph 1 | completed | Study to Evaluate the Effect of Multiple Doses of Itraconazole and Rifampin on the Single-Dose Pharmacokinetics of Mitapivat Sulfate (AG-348) in Healthy Adult Participants |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
AQVESME FDA Label Details
Indications & Usage
FDA Label (PDF)AQVESME is indicated for the treatment of Anemia; Thalassemia.
WARNING: HEPATOCELLULAR INJURY AQVESME can cause serious hepatocellular injury. Measure liver laboratory tests (ALT, AST, alkaline phosphatase, and total bilirubin with fractionation) at baseline and every 4 weeks for 24 weeks and then as clinically indicated. Avoid use of AQVESME in patients with c...
AQVESME Patents & Exclusivity
Patents (9 active)
Exclusivity
Pro Intelligence Preview
Deep insights for AQVESME
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2041
- • 33 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 15 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.