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Oral PTH (1-34)
Oral PTH (1-34) is a PTH receptor agonist Small molecule drug developed by Entera Bio Ltd.. It is currently in Phase 3 development for Osteoporosis in postmenopausal women, Osteoporosis in men at high risk of fracture. Also known as: Teriparatide, HPTH.
Oral PTH (1-34) activates parathyroid hormone receptors on bone cells to stimulate bone formation and increase bone mineral density.
Oral PTH (1-34) activates parathyroid hormone receptors on bone cells to stimulate bone formation and increase bone mineral density. Used for Osteoporosis in postmenopausal women, Osteoporosis in men at high risk of fracture.
At a glance
| Generic name | Oral PTH (1-34) |
|---|---|
| Also known as | Teriparatide, HPTH |
| Sponsor | Entera Bio Ltd. |
| Drug class | PTH receptor agonist |
| Target | PTH1 receptor (PTHR1) |
| Modality | Small molecule |
| Therapeutic area | Endocrinology / Bone Metabolism |
| Phase | Phase 3 |
Mechanism of action
PTH (1-34), also known as teriparatide, is the active N-terminal fragment of parathyroid hormone that binds to PTH1 receptors on osteoblasts. When administered intermittently, it shifts bone metabolism toward net bone formation by increasing osteoblast activity and bone turnover. Entera Bio's formulation uses proprietary oral delivery technology to enable systemic absorption of this peptide hormone, which traditionally required subcutaneous injection.
Approved indications
- Osteoporosis in postmenopausal women
- Osteoporosis in men at high risk of fracture
Common side effects
- Nausea
- Dizziness
- Headache
- Hypercalcemia
Key clinical trials
- Assess Safety and Compare PK of New Oral hPTH(1-34) Tablet Formulations vs. EBP05 Tablets and Subcutaneous Forteo (PHASE1)
- Novel Combination Therapy for Osteoporosis in Men (PHASE4)
- Study Evaluating PK of PTH Administered Orally Via RaniPill™ Capsule (PHASE1)
- A Six-month Phase 2 Study of Oral hPTH(1-34) (EBP05) in Postmenopausal Women With Low Bone Mass (PHASE2)
- Oral PTH(1-34) PK and PD Study in Patients With Hypoparathyroidism (PHASE2)
- A Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral PTH (1-34) Formulations in Healthy Subjects (PHASE1)
- Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34 (PHASE2)
- A Pilot Study to Assess the Safety and Efficacy of Oral PTH (1-34) in the Treatment of Hypoparathyroidism (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Oral PTH (1-34) CI brief — competitive landscape report
- Oral PTH (1-34) updates RSS · CI watch RSS
- Entera Bio Ltd. portfolio CI
Frequently asked questions about Oral PTH (1-34)
What is Oral PTH (1-34)?
How does Oral PTH (1-34) work?
What is Oral PTH (1-34) used for?
Who makes Oral PTH (1-34)?
Is Oral PTH (1-34) also known as anything else?
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What does Oral PTH (1-34) target?
Related
- Drug class: All PTH receptor agonist drugs
- Target: All drugs targeting PTH1 receptor (PTHR1)
- Manufacturer: Entera Bio Ltd. — full pipeline
- Therapeutic area: All drugs in Endocrinology / Bone Metabolism
- Indication: Drugs for Osteoporosis in postmenopausal women
- Indication: Drugs for Osteoporosis in men at high risk of fracture
- Also known as: Teriparatide, HPTH
- Compare: Oral PTH (1-34) vs similar drugs
- Pricing: Oral PTH (1-34) cost, discount & access