Ferric Carboxymaltose clinical trials
Ferric Carboxymaltose is named as an intervention in 9 current clinical trials in our China, France, USA, Poland, Spain, Netherlands, Belgium and Sweden registers. 7 are recruiting patients now. The most common phase is Phase 4. The sponsor with the most trials is AFT Pharmaceuticals, Ltd (1). The most-studied condition is Iron Deficiency. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Ferric Carboxymaltose is approved
All regulators →Of the three regulators tracked here, the first to approve Ferric Carboxymaltose was the US, on 25 Jul 2013. It is approved in 2 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Ferric Carboxymaltose patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Ferric Carboxymaltose, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 6 listed patents; the last listed expires 15 Feb 2028 (US 7754702).
- Latest patent on the drug substance itself: 5 Feb 2027 (US 7612109).
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Ferric Carboxymaltose
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Ferric Carboxymaltose works
All drug targets →- FatiguePhase 3
- Gastrointestinal hemorrhagePhase 3
- Anemia (phenotype)Phase 3
- Breast cancerPhase 3
- Burning mouth syndromePhase 3
- Chronic kidney diseasePhase 3
- FibromyalgiaPhase 3
- Gastric cancerPhase 3
- Heart failurePhase 3
- HypophosphatemiaPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL2108597, CC BY-SA 3.0. The Guide to Pharmacology has no record of this medicine, so its targets rest on ChEMBL alone. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Ferric Carboxymaltose
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 2 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Ferric Carboxymaltose
- ChEMBL
- CHEMBL2108597
- DrugBank
- DB08917
- PubChem CID
- 86278165
- CAS number
- 9007-72-1
- FDA UNII
- 6897GXD6OE
- Wikidata
- Q20817270
- Wikipedia
- Ferric carboxymaltose
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Ferric Carboxymaltose
9 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Ferric Carboxymaltose in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Ferric Carboxymaltose. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
Intravenous iron in the management of drug-resistant restless legs syndrome: a randomized controlled delayed-start trial. IRON-RLS
2026-525613-31-00 · CTIS ↗ · Nervous System Diseases
|
Phase 2 | Authorised | Centre Hospitalier Universitaire De Montpellier | France |
Ferric Carboxymaltose across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
2 single-substance products containing Ferric Carboxymaltose on the HPRA medicines list.
- Ferric carboxymaltose 50 mg iron/ml dispersion for injection/infusionRowex Limited, · PA0711/315/001 · Marketed
- Ferric carboxymaltose Teva 50 mg iron/ml dispersion for injection/infusionTeva B.V. · PA1986/124/001 · Marketed
Supply shortages
No entry for Ferric Carboxymaltose in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Ferric Carboxymaltose
17 conditionsAll 17 conditions
| Condition (as registered) | Trials |
|---|---|
| Iron Deficiency | 2 |
| Iron Deficiency Anemia (IDA) | 1 |
| Ferric Carboxymaltose | 1 |
| Healthy Adult | 1 |
| Postpartum Depression (PPD) | 1 |
| Restless Legs Syndrome (RLS) | 1 |
| Acute Coronary Syndromes (ACS) | 1 |
| Iron Deficiencies | 1 |
| Elderly (People Aged 65 or More) | 1 |
| Aortic Valve Stenosis | 1 |
| TAVI(Transcatheter Aortic Valve Implantation) | 1 |
| Cardiovascular Diseases | 1 |
| Pulmonary Hypertension | 1 |
| Surgery | 1 |
| Liver Metastases | 1 |
| Liver Cancer | 1 |
| Pancreas Cancer | 1 |
Sponsors
lead sponsor per trialBy country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Ferric Carboxymaltose trials
How many clinical trials are testing Ferric Carboxymaltose?
9 current trials in our China, France, USA, Poland, Spain, Netherlands, Belgium and Sweden registers name Ferric Carboxymaltose as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Ferric Carboxymaltose trials recruiting patients?
Yes. 7 of the 9 trials are recruiting: 2 with sites in China, 1 with sites in France, 1 with sites in Spain, 1 with sites in Netherlands, 1 with sites in Belgium and 1 with sites in Sweden. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Ferric Carboxymaltose clinical trials?
AFT Pharmaceuticals, Ltd (1), Xuanwu Hospital, Beijing (1), Sichuan Huiyu Pharmaceutical Co., Ltd (1) and Assistance Publique - Hôpitaux de Paris (1), among 9 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Ferric Carboxymaltose licensed in Ireland?
Yes. The HPRA medicines list includes 2 single-substance products containing Ferric Carboxymaltose, for example Ferric carboxymaltose 50 mg iron/ml dispersion for injection/infusion (Rowex Limited,). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Ferric Carboxymaltose shortage?
Not in the lists we track: Ferric Carboxymaltose has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Ferric Carboxymaltose works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Ferric Carboxymaltose works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Ferric Carboxymaltose (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.