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Accrufer (FERRIC MALTOL)
Accrufer (FERRIC MALTOL) is a small molecule developed by SHIELD TX UK LTD and currently owned by Shield Tx. It was FDA approved in 2019 for the treatment of iron deficiency anemia. Accrufer is a patented medication with no generic manufacturers available. Key safety considerations include the potential for gastrointestinal side effects. Accrufer is a commercially available treatment for iron deficiency anemia.
At a glance
| Generic name | FERRIC MALTOL |
|---|---|
| Sponsor | Shield Tx |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
| First approval | 2019 |
Approved indications
- Iron deficiency anemia
Common side effects
- Flatulence
- Diarrhea
- Constipation
- Feces discolored
- Abdominal pain
- Nausea
- Vomiting
- Abdominal Discomfort
- Abdominal Distension
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)
- 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)
- Evaluate the PK, Safety, Tolerability of Ferric Maltol at 3 Dosage Levels in Paediatric Subjects With Iron Deficiency (PHASE1)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Accrufer CI brief — competitive landscape report
- Accrufer updates RSS · CI watch RSS
- Shield Tx portfolio CI