Entera Bio Ltd Dossier
Qualitative Analysis
Business overview
Entera Bio Ltd. (NASDAQ: ENTX) is a clinical-stage biopharmaceutical company headquartered in Jerusalem, Israel, specializing in the development of orally delivered large molecule therapeutics. Utilizing its proprietary N-Tab™ oral peptide technology platform, the company aims to transform the delivery of macromolecule therapeutics, such as peptides and therapeutic proteins, which are traditionally administered via injection. Entera's lead product candidate is EB613, a first-in-class oral PTH(1-34) (teriparatide) osteoanabolic tablet designed for postmenopausal women with low bone mineral density (BMD) and high-risk osteoporosis. The company's pipeline also includes EB612, an oral long-acting PTH peptide replacement tablet for hypoparathyroidism, and EB618, an oral dual GLP-1/glucagon receptor agonist for metabolic and fibrotic conditions.
Research as of 20 Jun 2026
Strategic Initiatives
Growth programs, investments, and their expected impact
Advancing EB613, a once-daily oral tablet formulation of PTH(1-34) (teriparatide), toward a Phase 3 registrational study for post-menopausal osteoporosis. This follows the FDA's July 2025 alignment on using Bone Mineral Density (BMD) as the primary endpoint and the FDA's December 2025 qualification of total hip BMD as a surrogate endpoint.
Expected impact: Establishes the first oral anabolic (bone-building) tablet treatment for osteoporosis, addressing a massive underserved market currently limited by daily injections.
Developing a Next-Generation EB613 candidate designed to offer significant administration, commercial, and strategic advantages over the first-generation formulation.
Expected impact: Enhances the commercial value proposition and intellectual property barrier of the oral osteoporosis franchise.
Mergers, Acquisitions & Partnerships
Recent deals and strategic collaborations
Strategic Partnerships
Collaborating on multiple oral peptide programs utilizing Entera's proprietary N-Tab oral delivery technology. This includes the EB612 long-acting oral PTH program for hypoparathyroidism, the EB618 oral oxyntomodulin (OXM) program for obesity/metabolic syndromes, and an oral GLP-2 peptide program for short bowel syndrome.
Terms: In February 2026, the parties amended their agreement to expand the partnership to include the long-acting oral PTH program. Development expenses through Phase 1 are funded from the $8 million in proceeds received as part of OPKO's 2025 equity investment in Entera, with rights and subsequent development costs shared 50/50.