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, OPK-8801003, and OPK-88006. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
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:
- March 4, 2026
- Indication:
- Parathyroid hormone (1-34), or PTH for osteoporosis
Announcement
Entera Bio Ltd announced the submission to the U.S. Food and Drug Administration (FDA) of a clinical amendment providing a streamlined Phase 3 protocol, statistical analysis plan (SAP), and open-label extension synopsis to the Company's Investigational New Drug (IND) 505(b)(2) submission, to evaluate EB613 (Oral PTH(1-34), teriparatide). Entera anticipates FDA feedback within 60 days.
AI Summary
Entera Bio Ltd submitted a clinical amendment to its IND 505(b)(2) for EB613 (Oral PTH(1-34), teriparatide) that includes a streamlined Phase 3 protocol, a statistical analysis plan (SAP), and an open-label extension synopsis. The company expects to receive FDA feedback on the amendment within 60 days.
The Phase 3 design sets total hip bone mineral density (BMD) at 12 months as the primary endpoint instead of 24 months, and the single-tablet final commercial formulation (Next-Gen EB613) will replace the multi-tablet candidate directly in Phase 3. Entera plans to start the study in late 2026 and now targets topline data in the second half of 2028, roughly one year earlier than previously expected.
Entera also included a protocol for a 12-month open-label extension where participants would be randomized to EB613 through 12 or 24 months or switched to a standard anti-resorptive agent. The extension is planned to run in parallel with potential NDA review.Read Announcement
- Drug:
- EB613
- Announced Date:
- October 23, 2025
- Indication:
- Parathyroid hormone (1-34), or PTH for osteoporosis
Announcement
Entera Bio Ltd. today reported new clinical data from a post-hoc analysis of its Phase 2 trial of EB613, at the 2025 North American Menopause Society (NAMS) Annual Meeting in a poster presentation titled "EB613 (Oral PTH[1-34] Tablets) Increases BMD Over 6 Months in Early Postmenopausal Women with Low Bone Mass or Osteoporosis: A Phase 2 Randomized Trial (P-66)."
AI Summary
Entera Bio Ltd. presented new clinical data from a post-hoc analysis of its Phase 2 EB613 trial at the 2025 North American Menopause Society meeting. A poster titled “EB613 (Oral PTH[1-34] Tablets) Increases BMD Over 6 Months…” highlighted the treatment’s bone density effects.
EB613 is a once-daily oral PTH(1-34) anabolic tablet in development as the first oral bone-building therapy for postmenopausal women at high fracture risk. Injectable agents are underused due to injection and cost barriers.
In women within 10 years of menopause, EB613 at 2.5 mg increased lumbar spine BMD by 3.1% (p=0.05), total hip by 2.3% (p=0.03), and femoral neck by 2.0% versus placebo over six months. These gains matched improvements in women over 10 years post-menopause.
Investigators noted consistent response across menopause stages and said the oral option could allow earlier anabolic treatment with simpler use and better access.
Read Announcement- Drug:
- EB613
- Announced Date:
- October 16, 2025
- Indication:
- Parathyroid hormone (1-34), or PTH for osteoporosis
Announcement
Entera Bio Ltd. announced that it will present new clinical data from its Phase 2 trial of EB613 at the upcoming North American Menopause Society (NAMS) 2025 Annual Meeting, taking place October 21–25, 2025, in Orlando, Florida.
AI Summary
Entera Bio Ltd. announced it will present new clinical data from its Phase 2 trial of EB613 at the North American Menopause Society (NAMS) 2025 Annual Meeting, October 21–25, in Orlando, Florida. This is Entera’s first presentation at NAMS.
The data focus on early postmenopausal women with low bone mass or osteoporosis and examine bone mineral density changes over six months. By targeting this at-risk group, the trial explores using an oral anabolic tablet earlier in the care pathway, where injectable treatments remain underused.
“Anabolic therapies can rebuild bone but are underutilized because they require injections,” said CEO Miranda Toledano. “EB613’s oral tablet could move treatment earlier and broaden access for over 200 million women worldwide living with osteoporosis.”
The EB613 poster presentation (P-66) will take place on Thursday, October 23, 2025, from 6:15 PM to 7:15 PM in the Windemere Exhibit Hall.
Read Announcement- Drug:
- EB613
- Announced Date:
- September 8, 2025
- Indication:
- Parathyroid hormone (1-34), or PTH for osteoporosis
Announcement
Entera Bio Ltd. announced data selected for presentation at the American Society for Bone and Mineral Research ("ASBMR") 2025 Annual Meeting in Seattle, Washington, for its lead program EB613 which is in late stage clinical development for post-menopausal women with osteoporosis.
AI Summary
Entera Bio Ltd. will present new results for its oral osteoporosis drug, EB613, at the ASBMR 2025 meeting in Seattle. In a Phase 2 trial of post-menopausal women, daily 2.5 mg EB613 tablets for six months boosted both the spongy (trabecular) and hard (cortical) bone. Using 3D imaging, researchers saw hip bone density rise by up to 2.6% and thickness increase by 1.7% compared to placebo. These improvements suggest EB613 may quickly strengthen bones and reduce fracture risk.
Injectable anabolic treatments help few patients, so EB613’s tablet form could fill an important gap. Preclinical data for a next-generation EB613 tablet showed the same absorption and peak levels in minipigs as the current version. After FDA agreement in July 2025, Entera plans to begin a global Phase 3 registration study for EB613, aiming to make the first daily oral anabolic therapy widely available.
Read Announcement- Drug:
- EB613
- Announced Date:
- August 28, 2025
- Target Action Date:
- September 1, 2025
- Estimated Target Date Range:
- September 1, 2025 - September 30, 2025
- Indication:
- Parathyroid hormone (1-34), or PTH for osteoporosis
Announcement
Entera Bio Ltd. announced that the Company will present data across three key programs during September 2025.
AI Summary
Entera Bio Ltd. announced it will share new clinical and preclinical data across three key programs in September 2025. These presentations highlight progress toward better oral treatments for bone and gut disorders, as well as an update for investors.
At the American Society for Bone and Mineral Research (ASBMR) meeting, researchers will present Phase 2 results on EB613, an oral PTH(1-34) tablet for osteoporosis. The data show improvements in both trabecular and cortical bone density in postmenopausal women. A second poster will cover next-generation EB613 pharmacokinetics and pharmacodynamics using the company’s N-Tab™ technology.
At the European Society for Clinical Nutrition & Metabolism (ESPEN) Congress, Entera will share PK/PD results for its oral GLP-2 analog targeting short bowel syndrome. Finally, the CEO will give a corporate overview at the H.C. Wainwright Investor Conference in early September.
Read Announcement- Drug:
- EB613
- Announced Date:
- July 28, 2025
- Indication:
- Parathyroid hormone (1-34), or PTH for osteoporosis
Announcement
Entera Bio Ltd. announced that in a written response to a Type A meeting request, the U.S. Food and Drug Administration (FDA) agreed with the Company's proposal that the NDA marketing application filing for EB613 would be supported by a single multinational, randomized, double-blind, placebo-controlled, 24 month phase 3 study in women with postmenopausal osteoporosis, where change in total hip BMD is evaluated as the primary endpoint, and incidence of new or worsening vertebral fractures is evaluated as the key secondary endpoint.
AI Summary
Entera Bio Ltd. announced that the U.S. Food and Drug Administration agreed to support its plan for EB613’s marketing application. The proposal calls for one multinational, randomized, double-blind, placebo-controlled phase 3 trial in women with postmenopausal osteoporosis, running 24 months.
The primary endpoint will measure the change in total hip bone mineral density (BMD). The key secondary endpoint will track new or worsening vertebral fractures. This design marks a shift from past trials that used fracture rates as the main measure.
Miranda Toledano, Entera’s CEO, said the FDA’s agreement is a major milestone that reflects strong data and collaboration. It lets the company move forward without waiting for formal qualification of bone density as a regulatory endpoint.
EB613 is being developed as the first oral, once-daily anabolic tablet to build bone mass, improve bone structure, and reduce fracture risk in women with osteoporosis.
Read Announcement- 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.
Read Announcement
OPK-8801003 FDA Regulatory Events
OPK-8801003 is a drug developed by Entera Bio for the following indication: For Short Bowel Syndrome Patients.
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-8801003
- Announced Date:
- September 15, 2025
- Indication:
- For Short Bowel Syndrome Patients
Announcement
Entera Bio Ltd. announced the presentation of a poster titled "A First-in-Class Oral GLP-2 Analog for Treatment of Short Bowel Syndrome" at the 47th European Society for Clinical Nutrition & Metabolism (ESPEN) Congress in Prague, Czech Republic, highlighting pharmacokinetic (PK) data relating to its oral GLP-2 analog program.
AI Summary
Entera Bio Ltd. announced the presentation of a poster titled “A First-in-Class Oral GLP-2 Analog for Treatment of Short Bowel Syndrome” at the 47th European Society for Clinical Nutrition & Metabolism (ESPEN) Congress in Prague, Czech Republic. The poster highlighted key pharmacokinetic (PK) data for its oral GLP-2 analog program in preclinical studies with OPK-8801003.
In minipig studies, OPK-8801003 demonstrated a plasma half-life of about 15 hours—an 18-fold increase over the injectable therapy teduglutide. After a single oral dose, peak plasma levels (Cmax) reached roughly 200 ng/ml, compared with about 36.8 ng/ml for standard subcutaneous teduglutide in humans.
Systemic exposure (AUC) exceeded 2 h·μg/ml for more than 24 hours, supporting once-daily dosing. No toxicity was observed, indicating a favorable safety profile.
These results suggest the oral GLP-2 tablet could transform treatment for the 30,000 short bowel syndrome patients now dependent on daily injections, offering a less-invasive, personalized therapy option.
Read Announcement
OPK-88006 FDA Regulatory 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.
Read Announcement
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