Wednesday, July 8, 2026

Drug profile · INN

ferric derisomaltose

ferric derisomaltose (MONOFER) is a supplement. Associated with A.Menarini Australia Pty Limited. Route of administration: intravenous. Current US regulatory status: approved.

FDA: approved TGA: approved
US status approved
Patents linked 0
Pipeline programs 5
News articles 0
Drug details — ferric derisomaltose
US status
approved
Class
Route
INTRAVENOUS
Patents
0
Programs
5
Data quality
0.84

Quick answer

ferric derisomaltose (MONOFER) is a supplement. Associated with A.Menarini Australia Pty Limited. Route of administration: intravenous. Current US regulatory status: approved.

Key facts

INN ferric derisomaltose
Brand MONOFER
Mechanism Supplement
Route INTRAVENOUS
Formulation SOLUTION

Mechanism of action

Supplement

Approval history

Authority Status Date
FDA approved
TGA approved

Pipeline programs

  1. Monofer Phase 3 · Cosmo Pharmaceuticals · Chronic Kidney Disease Stage 5 (Dialysis Dependent)
  2. P-Monofer-CHF-02 Phase 3 · Anaxis Pharma · Chronic Heart Failure
  3. iron isomaltoside(Monofer®) Phase 3 · Hospital Authority · Anemia, Iron-Deficiency
  4. Ferric derisomaltose Approved · Chinese Academy of · Heart Failure With Reduced Ejection Fraction
  5. Ferric derisomaltose Approved · Chinese Academy of · Heart Failure With Preserved Ejection Fraction

Frequently asked questions

What is ferric derisomaltose?

ferric derisomaltose (MONOFER) is a supplement. Associated with A.Menarini Australia Pty Limited. Route of administration: intravenous. Current US regulatory status: approved.

What is the brand name for ferric derisomaltose?

MONOFER is a marketed brand name for ferric derisomaltose. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of ferric derisomaltose?

ferric derisomaltose has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.