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EnteraBio's Parathyroid Hormone

Phase 2

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

Success Probability

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

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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Frequently asked questions about EnteraBio's Parathyroid Hormone

What is EnteraBio's Parathyroid Hormone used for?

EnteraBio's Parathyroid Hormone is an investigational oral small molecule being developed for the treatment of hypoparathyroidism, a condition characterized by insufficient parathyroid hormone. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

Who makes EnteraBio's Parathyroid Hormone?

EnteraBio's Parathyroid Hormone is being developed by Entera Bio Ltd., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ENTX. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy for hypoparathyroidism.

What phase is EnteraBio's Parathyroid Hormone in?

EnteraBio's Parathyroid Hormone is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies and is still undergoing clinical trials to assess its safety and effectiveness in patients with hypoparathyroidism.

What clinical trials is EnteraBio's Parathyroid Hormone in?

EnteraBio's Parathyroid Hormone has one completed Phase 2 clinical trial, identified as NCT02152228. This was a pilot study conducted in Israel to assess the safety and efficacy of oral PTH (1-34) in the treatment of hypoparathyroidism, enrolling 20 adult participants.

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

Yes, EnteraBio's Parathyroid Hormone is also known as oral PTH (1-34), as referenced in the clinical trial title. This investigational therapy is being studied for its potential to treat hypoparathyroidism through oral administration of parathyroid hormone.