Monoferric

(Ferric derisomaltose)

ApprovedSmall molecule

PPharmacosmos A/S

Monoferric is one of 163 small molecule programs targeting Heart Failure. It is currently in Approved.

Indications

Total Trials

Active Trials

162

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Heart FailureCompleted

Heart Failure With Preserved Ejection FractionNot yet recruiting

Hip FractureActive, not recruiting

Iron Deficiency AnemiaRecruiting

AnemiaNot yet recruiting

PregnancyRecruiting

Iron-DeficiencyRecruiting

Enhanced Recovery After SurgeryRecruiting

Heart FailureApproved

Completed

Heart Failure With Preserved Ejection FractionApproved

Not yet recruiting

Hip FractureApproved

Active, not recruiting

Iron Deficiency AnemiaApproved

Recruiting

AnemiaApproved

Not yet recruiting

PregnancyPhase 3

Recruiting

Iron-DeficiencyPhase 1

Recruiting

Enhanced Recovery After SurgeryPhase 3

Recruiting

Competition

Competitive Landscape

206 competitors in Heart Failure

#DrugCompanyPhaseTrials

Monoferric

PPharmacosmos A/S

Approved

5 2

Bayer Aspirin

Bayer

Preclinical

2 3

Brethine

Sanofi

Preclinical

1 4

Medrol

Pfizer

Preclinical

1 5

Amidate

Pfizer

Preclinical

1 6

Activase

Zemplar

Xifaxan

2 9

Oraverse

LLife Extension Foundation Inc.

Preclinical

1 10

Xylocaine

MMEDRx USA, Inc.

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 3Recruiting

Enhanced Recovery After Surgery

NCT05407987

Q1 2027

Recruiting

Heart Failure

NCT06542822

Phase 3Recruiting

Pregnancy

NCT05462704

Q2 2027

Phase 3Recruiting

Anemia

NCT05179226

Q3 2027

Post-ApprovalRecruiting

Hip Fracture

NCT06898814

Clinical

Trials by Indication[1]

Anemia6 trials

A Clinical Trial Assessing the Efficacy of Intravenous Iron for the Treatment of Anemia Following Cardiac Surgery

Completed·MMichael Kremke·Phase 4·NCT04608539·110 enrolled

The Effects of Ferric Derisomaltose on Postoperative Anemia in Spinal Deformity Surgery

Recruiting·PPeking Union Medical College Hospital·Phase 4·NCT05714007·120 enrolled

High Dose IV Iron Plus ESA in Chemotherapy-induced Anemia

Unknown status·HHallym University Medical Center·Phase 3·NCT05768997·312 enrolled

Show 3 more trials

Postoperative Intravenous Ferric Derisomaltose for Prevention of Long-term Anemia After Cardiac Surgery

Not yet recruiting·YYonsei University·Phase 4·NCT07238972·180 enrolled

The Use of Preoperative Monoferric Infusion for Enhanced Recovery After Surgery-driven Elective Abdominal Surgery

Completed·BBrigham and Women's Hospital·Approved·NCT05258825·37 enrolled

A Phase III, Prospective, Open-label, Multi-center Trial of Ferric Derisomaltose in Children 0 to <18 Years of Age With Iron Deficiency Anemia Due to NDD-CKD or With Iron Deficiency Anemia Who Are Intolerant or Unresponsive to Oral Iron

Recruiting·PPharmacosmos A/S·Phase 3·NCT05179226·200 enrolled

Heart Failure5 trials

The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)

Unknown status·—·Phase 4·NCT05971732·146 enrolled

Multi-center Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure

Recruiting·PPharmacosmos A/S·Phase 3·NCT06929806·1,900 enrolled

The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life

Unknown status·—·Phase 4·NCT05991128·170 enrolled

Show 2 more trials

Intravenous Iron Treatment in Patients With Heart Failure and Iron Deficiency: IRONMAN

Completed·UUniversity of Glasgow·Phase 4·NCT02642562·1,160 enrolled

IRONHEART: Intravenous Iron in Non-ischaemic Heart Failure

Recruiting·UUniversity Hospital Southampton NHS Foundation Trust··NCT06542822·16 enrolled

Hip Fracture2 trials

The Effects of Intravenous Iron on Mobility in Elderly Patients Following Hip Fracture Surgery

Recruiting·SSoren Overgaard·Phase 4·NCT06898814·210 enrolled

IRONCARE: Iron Treatment in Older Patients With Hip Fractures - A Double-blinded Placebo-controlled Randomized Trial

Not yet recruiting·UUniversity of Aarhus·Approved·NCT07659184·528 enrolled

Heart Failure With Preserved Ejection Fraction2 trials

Intravenous Iron to Improve Symptoms, Quality of Life and Exercise Capacity in HFpEF With Iron Deficiency

Enrolling by invitation·GGovernment of Jersey·Phase 2·NCT07643818·150 enrolled

Iron Needed for Function and Undesirable Symptoms in Elderly With Heart Failure With Preserved Ejection Fraction

Not yet recruiting·DDuke University·Approved·NCT07686692·300 enrolled

Iron-deficiency1 trial

Monoferric for Prenatal Iron Deficiency

Recruiting·OOregon Health and Science University·Phase 1·NCT05763043·80 enrolled

4 more indications

Enhanced Recovery After Surgery1 trial

Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery)

Recruiting·AAHS Cancer Control Alberta·Phase 3·NCT05407987·82 enrolled

Pregnancy1 trial

Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy

Recruiting·WWomen and Infants Hospital of Rhode Island·Phase 3·NCT05462704·300 enrolled

Oncology1 trial

Ferric Derisomaltose/Iron Isomaltoside and Outcomes in the Recovery of Gynecologic Oncology ERAS

Unknown status·AAlberta Health Services, Calgary·Phase 3·NCT05467319·82 enrolled

Iron deficiency anemia1 trial

Iron Deficiency Anemia (IDA) and the Brain

Recruiting·—·Phase 4·NCT05929729·120 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 16, 2020

MONOFERRIC

NDA NDA208171

Sources

References

[1]
ClinicalTrials.gov — 20 trial records for Ferric derisomaltose. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Ferric derisomaltose compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Ferric derisomaltose. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA208171). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Monoferric. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Pharmacosmos A/S company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

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

Patent Landscape[5]

Patent Cliff

Mar 25, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10414831Mar 25, 2029

12030962Mar 25, 2029

11851504Mar 25, 2029

8815301Aug 14, 2029

11633489Jun 22, 2036

Monoferric

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Q3 2027

Trials by Indication[1]

Anemia6 trials

Heart Failure5 trials

Hip Fracture2 trials

Heart Failure With Preserved Ejection Fraction2 trials

Iron-deficiency1 trial

Enhanced Recovery After Surgery1 trial

Pregnancy1 trial

Oncology1 trial

Iron deficiency anemia1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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