Last reviewed · How we verify
Accrufer (MALTOL)
At a glance
| Generic name | MALTOL |
|---|---|
| Sponsor | Shield Tx |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
| First approval | 2025 |
Approved indications
- iron deficiency
Common side effects
- Flatulence
- Diarrhea
- Constipation
- Feces discolored
- Abdominal pain
- Nausea
- Vomiting
- Abdominal discomfort
- Abdominal distension
Drug interactions
- Dimercaprol
- Dimercaprol
- Mycophenolate
- Ethinyl estradiol
- Ciprofloxacin
- Doxycycline
- Oral Medications
Key clinical trials
- Efficacy and Tolerability of Sucrosomial® Iron vs Ferric Maltol in Iron Deficient Women (PHASE4)
- Perioperative Iron for Colorectal Cancer (PICoC Study) (PHASE3)
- Evaluate the Safety and Efficacy of Ferric Maltol Oral Suspension vs. Ferrous Sulfate Oral Liquid in Children and Adolescents Aged 2 to 17 Years With Iron-deficiency Anaemia, With a Single Arm Study in Infants Aged 1 Month to Less Than 2 Years (PHASE3)
- Testing the Effect of ENDS Flavors on Neurotransmission (NA)
- Four-Way Crossover Study to Compare Ferric Maltol Capsules and Oral Suspension in Healthy Volunteers (PHASE1)
- Evaluating the Effectiveness of Various Iron Salts in Oral Iron Therapy for Iron Deficiency and Anemia in Healthy Adults (NA)
- ORal IrON Supplementation with Ferric Maltol in Treating Iron Deficiency and Anaemia in Patients with Heart Failure (ORION-HF) (PHASE4)
- Predicting Response to Iron Supplementation in Patients With Active Inflammatory Bowel Disease (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 |