Entera Bio Ltd. and OPKO Health Inc. have expanded their partnership to develop a first‑oral, long‑acting parathyroid hormone (PTH) tablet for patients with hypoparathyroidism. The amended and restated collaboration and license agreement became effective on February 3 2026, and the companies announced the expansion on February 4 2026. Under the new terms, each company holds a 50 % pro‑rata ownership interest in the program and will fund 50 % of all development costs.
The expansion builds on Entera’s proprietary N‑Tab platform, which stabilizes peptides in the gastrointestinal tract and promotes their absorption, enabling oral delivery of peptide therapeutics. By partnering with OPKO, which brings advanced protein‑chemistry capabilities, the two firms aim to translate the platform’s success in earlier oral GLP‑2 and oxyntomodulin programs into a new therapeutic area. The move expands Entera’s commercial scope into a rare endocrine disorder and provides OPKO with a pathway to a novel treatment that could replace the current daily‑injection regimen used by hypoparathyroidism patients.
As part of the agreement, Steve Rubin, Executive Vice President of Administration at OPKO, was appointed to Entera’s board of directors, replacing former member Gerry Ostrov. Rubin’s appointment, effective February 1 2026, was approved as an independent director under SEC and Nasdaq rules, reflecting the deepening ties between the two companies.
The oral LA‑PTH candidate is expected to advance toward an Investigational New Drug filing in late 2026. Preclinical data released in December 2025 showed promising pharmacodynamic and pharmacokinetic profiles, suggesting that the tablet could provide sustained calcium regulation without the need for daily injections. The U.S. hypoparathyroidism market, estimated at roughly 50,000 patients, represents a niche but meaningful opportunity for an oral formulation that improves adherence and quality of life.
The broader context of oral peptide therapeutics is one of rapid growth, as companies seek to overcome long‑standing bioavailability challenges. Entera’s N‑Tab platform has already demonstrated clinical viability in other peptide programs, and the partnership positions both firms to capture a share of this expanding market. The collaboration also signals a strategic pivot for Entera toward rare disease indications and for OPKO toward oral delivery of peptide drugs.
Miranda Toledano, Entera’s CEO, said the preclinical data “suggests that this program holds the potential to transform the hypoparathyroidism landscape.” She added that the partnership with OPKO “leverages complementary expertise to accelerate development and bring a much‑needed oral therapy to patients.”
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