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Encaleret - BridgeBio Pharma

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Drug Profile

Encaleret - BridgeBio Pharma

Alternative Names: BBP-305; CLTX-305; Encaleret Sulfate

Latest Information Update: 05 Nov 2025

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At a glance

  • Originator Calcilytix therapeutix
  • Developer BridgeBio Pharma; Calcilytix Therapeutics
  • Class Amines; Benzoic acids; Calcium regulators; Ethers; Halogenated hydrocarbons; Osteoporosis therapies; Small molecules
  • Mechanism of Action Calcium-sensing receptor antagonists; Parathyroid hormone receptor agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Hypocalcaemia; Hypoparathyroidism
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Hypocalcaemia; Hypoparathyroidism

Most Recent Events

  • 29 Oct 2025 BridgeBio Pharma announces intention to submit New Drug Application (NDA) of encaleret to the US FDA in the first half of 2026
  • 29 Oct 2025 BridgeBio Pharma announces intention to submit Marketing Authorisation Application of encaleret to the EMA
  • 29 Oct 2025 Efficacy and adverse event data from the phase III CALIBRATE trial in Hypocalcaemia released by BridgeBio Pharma

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