OPKO and Entera Bio Accelerate Oral PTH Tablet Development for Hypoparathyroidism

Event summary

  • OPKO Health and Entera Bio expand their 2025 collaboration to advance an oral long-acting PTH tablet for hypoparathyroidism, aiming for an IND filing in late 2026.
  • The companies will share 50% ownership and development costs for the LA-PTH program, while maintaining a 60%/40% structure for the oral OXM program.
  • Steve Rubin, OPKO’s Executive Vice President, joins Entera’s board as Gerry Ostrov steps down.
  • Preliminary data suggests the oral PTH tablet could replace daily injections with a once-daily regimen at a lower dose.

The big picture

The expanded partnership between OPKO and Entera Bio underscores the growing interest in oral peptide therapies for rare endocrine disorders. The shift from injectable to oral formulations could redefine treatment paradigms for hypoparathyroidism, provided the companies overcome clinical and regulatory hurdles. The addition of Steve Rubin to Entera’s board also signals a strategic alignment in governance, potentially strengthening the collaboration’s long-term prospects.

What we're watching

Regulatory Milestones
Whether the IND filing for the oral PTH tablet meets the late 2026 target and how the FDA reviews the preclinical data.
Competitive Dynamics
How Entera and OPKO’s oral PTH tablet compares to Ascendis Pharma’s injectable YORVIPATH in efficacy and convenience.
Execution Risk
The pace at which the companies can transition from preclinical success to clinical validation for the oral PTH program.