Monofer

Phase 3Small molecule

PPharmacosmos A/S

Monofer is one of 89 small molecule programs targeting Inflammatory Bowel Disease. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Inflammatory Bowel DiseaseActive, not recruiting

Chronic Kidney DiseaseActive, not recruiting

Stage 5 Chronic Kidney DiseaseActive, not recruiting

Inflammatory Bowel DiseasePhase 1

Active, not recruiting

Chronic Kidney DiseasePhase 3

Active, not recruiting

Stage 5 Chronic Kidney DiseasePhase 1

Active, not recruiting

Competition

Competitive Landscape

540 competitors in Chronic Kidney Disease

#DrugCompanyPhaseTrials

Aranesp

Amgen

Preclinical

40 2

Monofer

PPharmacosmos A/S

Phase 3

1 3

Epogen

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Preclinical

16 4

Uloric

Takeda

Preclinical

3 5

Sovaldi

Gilead

Preclinical

1 6

Glucotrol

Pfizer

Preclinical

1 7

Vemlidy

Gilead

Preclinical

1 8

Lorelco

Sanofi

Preclinical

1 9

Activase

Flomax

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

Timeline

Expected Milestones

Q4 2027

Phase 3Recruiting

Peritoneal Dialysis

NCT06884280

Clinical

Trials by Indication[1]

Inflammatory Bowel Disease3 trials

Safety and Efficacy Extension Study of Iron Isomaltoside 1000 (Monofer®) in Subjects With Inflammatory Bowel Disease

Completed·PPharmacosmos A/S·Phase 3·NCT01410435·39 enrolled

Open-label PK Study of Iron Isomaltoside 1000 (Monofer) Administered by 500 mg IV Injection or 1000 mg IV Infusion to Patients With Inflammatory Bowel Disease

Completed·PPharmacosmos A/S·Phase 1·NCT01213680·16 enrolled

Iron Oligosaccharide in Inflammatory Bowel Disease Subjects With Iron Deficiency Anaemia

Completed·PPharmacosmos A/S·Phase 3·NCT01017614·350 enrolled

Maintenance Therapy1 trial

A Randomized, Comparative, Open-label Study of IV Monofer® Administered as Maintenance Therapy by Single or Repeated Bolus Injections in Comparison With IV Iron Sucrose in Subjects With CKD-5D

Completed·PPharmacosmos A/S·Phase 3·NCT01222884·351 enrolled

Intravenous1 trial

CArdio PulmOnary Exercise Testing and IntRAvenous Iron- 'CAPOEIRA-I STUDY'

Completed·UUniversity Hospital Southampton NHS Foundation Trust··NCT03346213·26 enrolled

Chronic Kidney Disease1 trial

Iron Isomaltoside 1000 (Monofer®) in Non-Dialysis Dependent Chronic Kidney Disease and With Renal-Related Anaemia

Completed·PPharmacosmos A/S·Phase 3·NCT01102413·351 enrolled

Age1 trial

ProPBM : A Modified Patient Blood Management Protocol

Unknown status·MMinistry of Health, Malaysia·N/A·NCT03888768·180 enrolled

5 more indications

Anti-inflammatory Therapy1 trial

Oral Versus Intravenous Iron in IBD Patients With Anti-inflammatory Therapy.

Unknown status·LLeiden University Medical Center·N/A·NCT05581420·152 enrolled

Stage 5 Chronic Kidney Disease1 trial

Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered as Single Bolus Injections in Subjects With Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D)

Completed·PPharmacosmos A/S·Phase 1·NCT01469078·18 enrolled

Renal Transplant1 trial

The Effect of Intravenous Iron Therapy and Erythropoiesis-stimulation Agent Combination on Renal Transplant Outcomes

Not yet recruiting·YYonsei University·Phase 4·NCT05719376·302 enrolled

Hematological Malignancies1 trial

Pharmacokinetic Study of Iron Isomaltoside 1000 Administered by 250 mg IV Bolus Injection or 500 mg Intravenous Infusion to Patients With Non-hematological Malignancies Associated With Chemotherapy Induced Anaemia

Completed·PPharmacosmos A/S·Phase 1·NCT01280240·11 enrolled

Peritoneal Dialysis1 trial

Comparing High and Low Dose Iron Treatments for People on Peritoneal Dialysis: The PALaDIN Study

Recruiting·HHull University Teaching Hospitals NHS Trust·Phase 3·NCT06884280·30 enrolled

Sources

References

[1]
ClinicalTrials.gov — 12 trial records for Monofer. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Monofer compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Monofer. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Pharmacosmos A/S company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: PPharmacosmos A/S

Monofer

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Trials by Indication[1]

Inflammatory Bowel Disease3 trials

Maintenance Therapy1 trial

Intravenous1 trial

Chronic Kidney Disease1 trial

Age1 trial

Anti-inflammatory Therapy1 trial

Stage 5 Chronic Kidney Disease1 trial

Renal Transplant1 trial

Hematological Malignancies1 trial

Peritoneal Dialysis1 trial

References

Drug Info

Quick Facts

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