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Accrufer

(Ferric maltol)

ApprovedSmall molecule

SShield Therapeutics

Ferric maltol is an iron supplement used to treat or prevent anemia, a condition where the body doesn't have enough red blood cells. It provides iron that your body needs to make new red blood cells when diet alone isn't supplying enough.[2] Accrufer is currently approved and in use across 5 indications[4].[1]

Accrufer is one of 159 small molecule programs targeting Pulmonary Hypertension. It is currently in Approved.

5

Indications

11

Total Trials

1

Active Trials

158

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

3

Patents

Pipeline

Status by Indication[4][1]

Indication

Pulmonary HypertensionActive, not recruiting

Inflammatory Bowel DiseaseActive, not recruiting

Colorectal CancerActive, not recruiting

Heart FailureActive, not recruiting

Chronic Kidney DiseaseActive, not recruiting

Pulmonary HypertensionPhase 3

Active, not recruiting

Inflammatory Bowel DiseaseApproved

Active, not recruiting

Colorectal CancerPhase 3

Active, not recruiting

Heart FailureApproved

Active, not recruiting

Chronic Kidney DiseasePhase 3

Active, not recruiting

Competition

Competitive Landscape

949 competitors in Colorectal Cancer

#DrugCompanyPhaseTrials

Accrufer

SShield Therapeutics

Emend IV

PORTRAZZA

Gas-X

PPortuguese Oncology Institute, Coimbra

Ketalar

AAultman Health Foundation

Xylocaine

MMEDRx USA, Inc.

Versed

CConrado Roberto Hoffmann Filho

Ultiva

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Bridion

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Andriol

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

Efficacy

NCT07308769

Clinical

Trials by Indication[1]

Heart Failure2 trials

ORal IrON Supplementation With Ferric Maltol in Patients With Heart Failure Carrying Left Ventricular Assist Devices

Terminated·HHannover Medical School·Phase 4·NCT03774615·11 enrolled

ORal IrON Supplementation with Ferric Maltol in Treating Iron Deficiency and Anaemia in Patients with Heart Failure (ORION-HF)

Completed·HHannover Medical School·Phase 4·NCT05697211·50 enrolled

Safety and Efficacy2 trials

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

Completed·SShield Therapeutics·Phase 3·NCT05126901·65 enrolled

Safety and Efficacy Study of Oral Ferric Maltol Compared to Intravenous Iron To Treat Iron Deficiency Anaemia in IBD

Completed·SShield Therapeutics·Phase 3·NCT02680756·250 enrolled

Inflammatory Bowel Disease1 trial

Predicting Response to Iron Supplementation in Patients With Active Inflammatory Bowel Disease

Unknown status·LLeiden University Medical Center·Phase 4·NCT05456932·90 enrolled

Chronic Kidney Disease1 trial

Study With Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects With Chronic Kidney Disease

Completed·SShield Therapeutics·Phase 3·NCT02968368·167 enrolled

Colorectal Cancer1 trial

Perioperative Iron for Colorectal Cancer (PICoC Study)

Completed·TThe Royal Wolverhampton Hospitals NHS Trust·Phase 3·NCT05177484·40 enrolled

4 more indications

Pulmonary Hypertension1 trial

ORal IrON Supplementation With Ferric Maltol in Patients With Pulmonary Hypertension (ORION-PH-1)

Terminated·HHannover Medical School·Phase 3·NCT03371173·22 enrolled

Oral1 trial

Four-Way Crossover Study to Compare Ferric Maltol Capsules and Oral Suspension in Healthy Volunteers

Completed·SShield Therapeutics·Phase 1·NCT04626414·32 enrolled

Efficacy1 trial

Efficacy and Tolerability of Sucrosomial® Iron vs Ferric Maltol in Iron Deficient Women

Recruiting·PPharmanutra S.p.a.·Phase 4·NCT07308769·146 enrolled

Iron-deficiency1 trial

Evaluate the PK, Safety, Tolerability of Ferric Maltol at 3 Dosage Levels in Paediatric Subjects With Iron Deficiency

Completed·SShield Therapeutics·Phase 1·NCT03181451·37 enrolled

Regulatory

FDA Approval Timeline[5]

Jul 25, 2019

ACCRUFER

NDA NDA212320

Sources

References

[1]
ClinicalTrials.gov — 11 trial records for Ferric maltol. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Accrufer drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Ferric maltol compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Ferric maltol. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA212320). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Accrufer. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Shield Therapeutics company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: SShield Therapeutics

Patent Landscape[6]

Patent Cliff

Mar 29, 2031

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9248148Mar 29, 2031

10179120Jan 6, 2035

9802973Oct 23, 2035

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