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EnteraBio's Parathyroid Hormone

Phase 2

Hypoparathyroidism | Small molecule | Endocrine |Entera Bio Ltd.|Trials Updated: Oct 7, 2015

EnteraBio's Parathyroid Hormone target and mechanism

ModalitySmall molecule

Also known as EnteraBio's Oral Parathyroid Hormone (1-34)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

EnteraBio's Parathyroid Hormone clinical trials

EnteraBio's Parathyroid Hormone · 1 trial · 1 indication

Phase 2 1
NCT02152228A Pilot Study to Assess the Safety and Efficacy of Oral PTH (1-34) in the Treatment of HypoparathyroidismHypoparathyroidism
COMPLETED20 Analytics
PHASE2COMPLETED
A Pilot Study to Assess the Safety and Efficacy of Oral PTH (1-34) in the Treatment of Hypoparathyroidism
HypoparathyroidismUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with adverse events
up to 17 weeks

safety will be measured by monitoring and recording adverse events related to hyper- and hypocalcemia

Reduction in use of exogenous calcium supplement and/or alpha D3 supplement
up to 17 weeks
Tolerability- The rate of discontinuation of patients' participation in the study due to adverse events
up to 17 weeks
Plasma calcium levels
at baseline and 60 minutes post-dose
Peak Plasma Concentration (Cmax)of treatment
at baseline and time-points post-dose

To study the pharmacokinetic profile of PTH absorption

Secondary Endpoints

The volunteers' compliance to treatment
up to 17 weeks
Patient quality of life
up to 17 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Oral Parathyroid Hormone (1-34)EXPERIMENTALOral administration of EnteraBio's Oral Parathyroid Hormone (1-34)

Interventions

NameTypeDescription
EnteraBio's Oral Parathyroid Hormone (1-34)DRUGOral administration
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Confirmed diagnosis of primary hypoparathyroidism for more than 1 year. * Currently taking \>1.0 grams of Calcium/day with a correlate alpha D3 dose. * 25(OH)D levels ≥ 20 ng/ml. * Signed informed consent. * BMI 18 - 30 kg/m2, inclusive. * Full blood count should be within the...

Countries:Israel
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Competitive Landscape -Hypoparathyroidism 9 trials

Frequently asked questions about EnteraBio's Parathyroid Hormone

What is EnteraBio's Parathyroid Hormone used for?

EnteraBio's Parathyroid Hormone is being developed for the treatment of hypoparathyroidism, a condition in which the body produces insufficient parathyroid hormone. It is an oral formulation of parathyroid hormone (1-34) intended to replace the missing hormone. The drug is investigational and has been studied in a Phase 2 clinical trial.

Who is developing EnteraBio's Parathyroid Hormone?

EnteraBio's Parathyroid Hormone is being developed by Entera Bio Ltd., a clinical-stage biopharmaceutical company. Entera Bio Ltd. trades on the Nasdaq under the ticker symbol ENTX. The company focuses on oral peptide and protein therapeutics.

What phase is EnteraBio's Parathyroid Hormone in?

EnteraBio's Parathyroid Hormone is in Phase 2 clinical development. A Phase 2 pilot study has been completed. The drug is investigational and has not been approved by the FDA or any other regulatory agency for any indication.

What clinical trials is EnteraBio's Parathyroid Hormone in?

EnteraBio's Parathyroid Hormone has been studied in one completed clinical trial: NCT02152228, titled "A Pilot Study to Assess the Safety and Efficacy of Oral PTH (1-34) in the Treatment of Hypoparathyroidism." This Phase 2 trial enrolled 20 participants in Israel and is now completed. No active trials are currently listed.

Is EnteraBio's Parathyroid Hormone the same as EnteraBio's Oral Parathyroid Hormone (1-34)?

Yes, EnteraBio's Parathyroid Hormone is also known as EnteraBio's Oral Parathyroid Hormone (1-34). Both names refer to the same investigational oral formulation of parathyroid hormone (1-34) being developed by Entera Bio Ltd. for hypoparathyroidism.