{"id":"oral-pth-1-34","safety":{"commonSideEffects":[{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Hypercalcemia"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"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.","oneSentence":"Oral PTH (1-34) activates parathyroid hormone receptors on bone cells to stimulate bone formation and increase bone mineral density.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:24:52.654Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Osteoporosis in postmenopausal women"},{"name":"Osteoporosis in men at high risk of fracture"}]},"trialDetails":[{"nctId":"NCT05965167","phase":"PHASE1","title":"Assess Safety and Compare PK of New Oral hPTH(1-34) Tablet Formulations vs. EBP05 Tablets and Subcutaneous Forteo","status":"COMPLETED","sponsor":"Entera Bio Ltd.","startDate":"2023-05-11","conditions":"Hypoparathyroidism, Osteoporosis, Fractures, Bone","enrollment":45},{"nctId":"NCT03994172","phase":"PHASE4","title":"Novel Combination Therapy for Osteoporosis in Men","status":"ACTIVE_NOT_RECRUITING","sponsor":"VA Office of Research and Development","startDate":"2019-07-01","conditions":"Male Osteoporosis","enrollment":40},{"nctId":"NCT05164614","phase":"PHASE1","title":"Study Evaluating PK of PTH Administered Orally Via RaniPill™ Capsule","status":"COMPLETED","sponsor":"RANI Therapeutics","startDate":"2022-02-21","conditions":"Healthy Volunteers","enrollment":50},{"nctId":"NCT04003467","phase":"PHASE2","title":"A Six-month Phase 2 Study of Oral hPTH(1-34) (EBP05) in Postmenopausal Women With Low Bone Mass","status":"COMPLETED","sponsor":"Entera Bio Ltd.","startDate":"2019-06-30","conditions":"Osteoporosis","enrollment":161},{"nctId":"NCT03516773","phase":"PHASE2","title":"Oral PTH(1-34) PK and PD Study in Patients With Hypoparathyroidism","status":"COMPLETED","sponsor":"Entera Bio Ltd.","startDate":"2018-06-17","conditions":"Hypoparathyroidism","enrollment":20},{"nctId":"NCT02571140","phase":"PHASE1","title":"A Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral PTH (1-34) Formulations in Healthy Subjects","status":"COMPLETED","sponsor":"Entera Bio Ltd.","startDate":"2013-10","conditions":"Drug Safety and Bioavailability","enrollment":30},{"nctId":"NCT00001304","phase":"PHASE2","title":"Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34","status":"COMPLETED","sponsor":"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","startDate":"1991-10","conditions":"Hypoparathyroidism","enrollment":27},{"nctId":"NCT02152228","phase":"PHASE2","title":"A Pilot Study to Assess the Safety and Efficacy of Oral PTH (1-34) in the Treatment of Hypoparathyroidism","status":"COMPLETED","sponsor":"Entera Bio Ltd.","startDate":"2014-07","conditions":"Hypoparathyroidism","enrollment":20},{"nctId":"NCT02202603","phase":"PHASE1","title":"A Three Stage, Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral PTH (1-34) in Healthy Subjects","status":"COMPLETED","sponsor":"Entera Bio Ltd.","startDate":"2011-07","conditions":"Drug Safety","enrollment":42},{"nctId":"NCT00277706","phase":"PHASE1","title":"Impact of Parathyroid Hormone (PTH) on Osseous Cavity","status":"COMPLETED","sponsor":"University of Michigan","startDate":"2004-08","conditions":"Bone Loss, Periodontitis","enrollment":40}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":135,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Teriparatide","HPTH"],"phase":"phase_3","status":"active","brandName":"Oral PTH (1-34)","genericName":"Oral PTH (1-34)","companyName":"Entera Bio Ltd.","companyId":"entera-bio-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"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.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}