MONOFERRIC (ferric derisomaltose)
Monoferric treats iron deficiency anemia in adults who cannot tolerate oral iron supplements or have not had success with them. It is also used for patients with chronic kidney disease who are not currently on hemodialysis. This medication serves as an iron replacement to help restore healthy levels when oral options are not an effective choice.
How MONOFERRIC Works
Monoferric works by releasing iron from a carbohydrate complex into the body. This iron then binds to transferrin, a transport protein that carries it to developing red blood cells where it is incorporated into hemoglobin.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2020-01-16
- Patent Cliff
- 2036
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
MONOFERRIC Approval History
What MONOFERRIC Treats
2 indicationsMONOFERRIC is approved for 2 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Iron Deficiency Anemia
- Chronic Kidney Disease
MONOFERRIC Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to MONOFERRIC
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05179226 | P-Monofer-PED-01 U1111-1266-9073 | Ph 3 | recruiting | Multi-center Trial of Ferric Derisomaltose in Children 0 to <18 Years of Age With Iron Deficiency Anemia |
| NCT06898814 IronHip | IronHip Trial 2024-515116-42-00 | Ph 4 | recruiting | The Effects of Intravenous Iron on Mobility in Elderly Patients Following Hip Fracture Surgery |
| NCT07238972 | 4-2025-1187 | Ph 4 | not yet recruiting | Postoperative Intravenous Ferric Derisomaltose for Prevention of Long-term Anemia After Cardiac Surgery |
| NCT06929806 ICONIC-HF | P-Monofer-CHF-02 | Ph 3 | recruiting | Multi-center Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure |
| NCT05714007 | PUMCH-Fe | Ph 4 | recruiting | The Effects of Ferric Derisomaltose on Postoperative Anemia in Spinal Deformity Surgery |
| NCT05462704 IVIDA2 | Pro00060930 | Ph 3 | recruiting | Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy |
| NCT05407987 FORGE II | FORGE II | Ph 3 | recruiting | Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery) |
| NCT05929729 IDA | CHLA-23-00173 1R01NS117430-01 | Ph 4 | recruiting | Iron Deficiency Anemia (IDA) and the Brain |
| NCT04608539 PICS | PICS-01 | Ph 4 | completed | A Clinical Trial Assessing the Efficacy of Intravenous Iron for the Treatment of Anemia Following Cardiac Surgery |
| NCT02642562 IRONMAN | GN15CA190 | Ph 4 | completed | Intravenous Iron Treatment in Patients With Heart Failure and Iron Deficiency: IRONMAN |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MONOFERRIC FDA Label Details
Indications & Usage
FDA Label (PDF)MONOFERRIC is indicated for the treatment of Iron Deficiency Anemia; Chronic Kidney Disease.
MONOFERRIC Patents & Exclusivity
Patents (5 active)
Pro Intelligence Preview
Deep insights for MONOFERRIC
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2036
- • 45 active patents
Trial Analysis
- • 10 total trials
- • Stage: Expansion
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment