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FG2216

Phase 2

Renal Anemia | Small molecule | Hematology |Kyntra Bio, Inc.|Last Updated: Nov 6, 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment145

FDA Designations

No designations recorded

Clinical trial landscape

FG2216 · 1 trial · 1 indication

Phase 2 1
NCT00456053A Randomized Study of the Safety and Efficacy of FG-2216 in Subjects With Renal Anemia Not Requiring Dialysis and Not Receiving Recombinant Human ErythropoietinRenal Anemia
COMPLETED145 Analytics
PHASE2COMPLETED
A Randomized Study of the Safety and Efficacy of FG-2216 in Subjects With Renal Anemia Not Requiring Dialysis and Not Receiving Recombinant Human Erythropoietin
Renal AnemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Hemoglobin (Hb) response

Secondary Endpoints

Attainment of Hb target range (11-13)
Duration of maintenance of Hb in target range (11-13)
Safety
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelFACTORIAL
PurposeTREATMENT

Interventions

NameTypeDescription
FG2216DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites27

Inclusion Criteria: * Stage 3 or 4 chronic kidney disease * appropriate hemoglobin levels Exclusion Criteria: * Neovascular age related macular degeneration requiring treatment * Macular edema or proliferative retinopathy in diabetic subjects, requiring treatment * Any history of malignancy * The...

Countries:United States
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Frequently asked questions about FG2216

What is FG2216 used for?

FG2216 is an investigational small molecule being developed for the treatment of renal anemia, a condition of low red blood cell counts associated with chronic kidney disease. It is currently in Phase 2 clinical development and has not been approved by the FDA.

How does FG2216 work?

FG2216 is a small molecule that targets hypoxia-inducible factor (HIF) pathways, which play a role in the body's response to low oxygen levels and stimulate erythropoietin production. This mechanism is intended to address anemia in patients with renal disease.

Who is developing FG2216?

FG2216 is being developed by Kyntra Bio, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol KYNB.

What phase is FG2216 in?

FG2216 is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval and is still being studied for safety and efficacy in clinical trials.

What clinical trials is FG2216 in?

FG2216 has one completed Phase 2 clinical trial, identified as NCT00456053. This randomized study evaluated the safety and efficacy of FG-2216 in 145 subjects with renal anemia who were not requiring dialysis and not receiving recombinant human erythropoietin. The trial was conducted in the United States.

Is FG2216 the same as FG-2216?

Yes, FG2216 and FG-2216 refer to the same investigational drug. The compound is also known by the name FG-2216, and both names are used interchangeably in clinical research and development contexts.