This section highlights FDA-related milestones and regulatory updates for drugs developed by Entera Bio (ENTX).
Over the past two years, Entera Bio has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
EB613 and OPK-88006. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
EB613 - FDA Regulatory Timeline and Events
EB613 is a drug developed by Entera Bio for the following indication: Parathyroid hormone (1-34), or PTH for osteoporosis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- EB613
- Announced Date:
- February 19, 2025
- Indication:
- Parathyroid hormone (1-34), or PTH for osteoporosis
Announcement
Entera Bio Ltd. announced that the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO) Scientific Programme Committee has accepted both submitted abstracts related to EB613 for presentation at the WCO-IOF-ESCEO congress.
AI Summary
Entera Bio Ltd. announced that the Scientific Programme Committee of the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO) has accepted both of its submitted abstracts related to its product candidate EB613. These abstracts will be presented at the upcoming congress in Rome, Italy, which takes place from April 10-13, 2025. One abstract, titled “EFFECTS OF EB613 TABLETS [ORAL PTH(1-34)] ON TRABECULAR AND CORTICAL BONE USING 3D-DXA: POST-HOC RESULTS FROM PHASE 2 STUDY,” is scheduled for an oral presentation on April 11 at 10:00 GMT in Auditorium A. The other abstract, “EB613 TABLET TREATMENT [ORAL PTH(1-34)] – DOES PK DRIVE BONE MODELING VERSUS BONE REMODELING?” will be presented as a poster from April 11 to April 13. The presentations will highlight new insights into EB613, a once-daily oral anabolic therapy for high-risk post-menopausal women with osteoporosis.
Read Announcement- Drug:
- EB613
- Announced Date:
- August 1, 2024
- Indication:
- Parathyroid hormone (1-34), or PTH for osteoporosis
Announcement
Entera Bio Ltd announced that new comparative pharmacological data for its investigational agent EB613 vs. Forteo® was selected for presentation at the American Society for Bone and Mineral Research (ASBMR) 2024 Annual Meeting which will be held on September 27-30, 2024 in Toronto, ON, Canada.
AI Summary
Entera Bio Ltd announced that new comparative pharmacological data for its investigational agent EB613 versus Forteo® has been selected for presentation at the American Society for Bone and Mineral Research (ASBMR) 2024 Annual Meeting in Toronto, Canada. The session is set for September 27-30, 2024, and will highlight results from a Phase 1b open-label study showing that EB613 has a differentiated pharmacokinetic profile compared to Forteo®. EB613 is being developed as the first once-daily oral anabolic therapy aimed at helping post-menopausal women with high-risk osteoporosis. The presentation at ASBMR 2024 is expected to provide valuable insights into how EB613 might offer a more convenient, tablet-based alternative to current injectable treatments, addressing a major unmet need in osteoporosis care and potentially transforming the standard of treatment for patients managing bone health.
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OPK-88006 - FDA Regulatory Timeline and Events
OPK-88006 is a drug developed by Entera Bio for the following indication: for patients with obesity, metabolic and fibrotic disorders.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- OPK-88006
- Announced Date:
- June 25, 2025
- Indication:
- for patients with obesity, metabolic and fibrotic disorders.
Announcement
OPKO Health, Inc and Entera Bio Ltd. announced that new pharmacologic and pharmacokinetic in vivo data for investigational oral OPK-88006 tablet treatment has been selected for presentation at the ENDO 2025 annual meeting of the Endocrine Society, taking place July 12-15, 2025 in San Francisco, CA, USA.
AI Summary
OPKO Health, Inc. and Entera Bio Ltd. have announced that new in vivo pharmacologic and pharmacokinetic data on their investigational oral OPK-88006 tablet will be presented at the ENDO 2025 annual meeting of the Endocrine Society. The event is scheduled for July 12-15, 2025 in San Francisco, CA, USA. This innovative tablet is being developed as part of a collaboration to treat obesity, metabolic disorders, and fibrotic conditions using a novel dual agonist GLP-1/glucagon peptide. The treatment aims to offer a once-daily dosage as a tablet, complementing an additional weekly injection format. The clinical study results highlight the promising potential of oral peptide therapy, which is rare in metabolic treatment. The ability to tailor therapies could improve patient management by optimizing treatment induction and maintenance regimens for individuals facing related health challenges.
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