OPKO and Entera Accelerate Oral PTH Tablet Development for Hypoparathyroidism

  • OPKO Health and Entera Bio expand their partnership to develop an oral long-acting PTH tablet for hypoparathyroidism, aiming for an IND filing by late 2026.
  • The companies will share 50% ownership and development costs for the LA-PTH program, while maintaining a 60/40 split for their oral OXM program.
  • Steve Rubin, OPKO’s Executive Vice President, joins Entera’s board as Gerry Ostrov steps down.

This expanded partnership underscores a strategic push toward oral peptide therapies, addressing unmet needs in rare endocrine disorders. The shift from injectables to tablets could redefine treatment convenience and patient compliance, while Entera’s board change signals deeper operational integration between the two firms.

Regulatory Milestones
Whether the accelerated timeline for the IND filing will hold, given the complexity of oral peptide delivery.
Competitive Dynamics
How this collaboration positions OPKO and Entera against Ascendis Pharma’s injectable PTH treatment, YORVIPATH®.
Execution Risk
The pace at which preclinical data translates into clinical success for the oral LA-PTH program.
A Pill to Replace the Needle: The Quest for an Oral Hypoparathyroidism Drug