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Ferric carboxymaltose

Phase 1

Iron Deficiency Anemia | Small molecule | Hematology |Novartis AG|Last Updated: May 30, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment71

FDA Designations

No designations recorded

Clinical trial landscape

Ferric carboxymaltose · 1 trial · 1 indication

Phase 1 1
NCT03399084A Study Comparing Two Ferric Carboxymaltose Formulations in Patients With Iron Deficiency AnemiaIron Deficiency Anemia
COMPLETED71 Analytics
PHASE1COMPLETED
A Study Comparing Two Ferric Carboxymaltose Formulations in Patients With Iron Deficiency Anemia
Iron Deficiency AnemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence assessed by maximum serum concentration (Cmax)of serum total iron.
Up to 7 days

Measured by Cmax - The maximum plasma concentration of iron

Bioequivalence assessed by area under the serum concentration-time curve (AUC) of serum total iron.
Up to 7 Days

Plasma Pharmacokinetics (PK) of study medication: Area Under the Plasma Concentration-time Curve (AUC)

Secondary Endpoints

Maximum serum concentration (Cmax) of serum transferrin-bound iron.
Up to 7 days
Time of Cmax (Tmax) of serum total iron and transferrin-bound iron
Up to 7 Days
Area under the serum concentration-time curve (AUC) of serum transferrin-bound iron
Up to 7 Days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeOTHER

Treatment Arms

ArmTypeDescription
Ferric carboxymaltose (test)EXPERIMENTALPatients will receive a single dose of Ferric carboxymaltose
Ferric carboxymaltose (reference)ACTIVE_COMPARATORPatients will receive a single dose of Ferric carboxymaltose

Interventions

NameTypeDescription
Ferric carboxymaltoseDRUG750 mg/15 mL
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male and female patients at least 18 - 65 years of age; * Patients with a body mass index (BMI) between 18.5 - 35 and with a body weight of ≥50 kg - ≤130 kg; Exclusion Criteria: * Patients with known hypersensitivity to ferric carboxymaltose, excipients, or similar product *...

Countries:United States
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Frequently asked questions about Ferric carboxymaltose

What is Ferric carboxymaltose used for?

Ferric carboxymaltose is used for the treatment of Iron Deficiency Anemia. It is an investigational small molecule being developed by Novartis AG. The drug is currently in Phase 1 clinical development, and it has been studied in patients with this condition.

Who makes Ferric carboxymaltose?

Ferric carboxymaltose is being developed by Novartis AG, which is publicly traded under the ticker symbol NVS. The company is conducting clinical research on this drug for the treatment of Iron Deficiency Anemia.

What phase is Ferric carboxymaltose in?

Ferric carboxymaltose is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The drug is being studied for the treatment of Iron Deficiency Anemia.

What clinical trials is Ferric carboxymaltose in?

Ferric carboxymaltose has been studied in one clinical trial, NCT03399084, which was a Phase 1 study comparing two formulations of the drug in patients with Iron Deficiency Anemia. The trial was completed and enrolled 71 participants in the United States.

Is Ferric carboxymaltose the same as iron carboxymaltose?

Ferric carboxymaltose is also known as iron carboxymaltose. The drug is being developed by Novartis AG for the treatment of Iron Deficiency Anemia and is currently in Phase 1 clinical development.