Pipeline

EB613 (Oral PTH(1-34),teriparatide) is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for post-menopausal women with low bone mineral density (“BMD”) and high-risk osteoporosis. EB613 is intended to provide an oral anabolic treatment earlier in an osteoporosis patient’s journey to increase skeletal mass, reduce the risk of fracture, potentially limit the progression of the disease, and its associated disability and mortality.

The EB612 program is being developed as the first oral long-acting proprietary PTH analog tablet peptide replacement therapy for hypoparathyroidism. The proprietary PTH analog with the new generation of N-Tab® oral peptide platform achieved sustained calcium elevation for >3 days from single oral tablet, supporting development path toward once-daily alternative to daily injections.

First GLP-1/Glucagon Agonist (Oxyntomodulin) Peptide Tablet Candidate for Obesity and Metabolic Diseases

• The program is focused on developing the first oral dual agonist GLP-1/glucagon peptide as a potential once-daily treatment for patients with obesity and metabolic disorders combining OPKO’s proprietary long-acting oxyntomodulin analog (OPK-88006) and Entera’s proprietary N-Tab™ platform. In September 2024, Entera and OPKO Health jointly announced topline pharmacokinetic/ pharmacodynamic (PK/PD) results for the oral oxyntomodulin (OXM) tablet program.

• Oral OXM exhibited significant systemic exposure across two in vivo models, a favorable PK profile and bioavailability. The high plasma concentrations with prolonged systemic exposure were consistent with the reported half-life for semaglutide (Rybelsus®), the only approved oral GLP-1 analog. Oral OXM showed a statistically significant reduction in plasma glucose levels compared with placebo.

• In March 2025, we entered into a collaboration and license agreement with OPKO relating to the preclinical and clinical development of the Oral OXM program. The companies expect to file an IND with FDA late in H1 2026.

First GLP-2 Peptide Tablets for Short Bowel Syndrome
Given the challenging compliance rates attributed to injectable GLP-2 therapy and heterogeneity of short bowel syndrome (SBS) patients, we believe a daily tablet format may address a significant unmet need in treating and titrating SBS patients more effectively than injectable alternatives.
In September 2023, we entered into a research collaboration with OPKO Biologics, whereby OPKO supplies its proprietary long-acting GLP-2 peptide for short bowel syndrome (SBS) using our proprietary N-Tab™ technology.

We completed a proof of concept (PoC) single dose pharmacokinetic study in rodents. Oral GLP-2 tablets exhibited significant systemic exposure. Furthermore, GLP-2 tablet exhibited a plasma half-life of approximately 15 hours, representing an 18-fold improvement over teduglutide (Gattex®), the only approved GLP-2 therapy, which requires a daily injection. The daily GLP-2 tablet candidate could fundamentally change how SBS patients are treated, offering a less-invasive administration that can be titrated to enable personalized dosing in this rare and heterogeneous condition.