Encaleret for Autosomal dominant hypocalcemia type 1 (ADH1)
The FDA is expected to decide on Encaleret for Autosomal dominant hypocalcemia type 1 (ADH1) by May 8, 2027, under an NDA from BridgeBio Pharma.
What is being decided
BridgeBio Pharma has an NDA under FDA review for Encaleret in Autosomal dominant hypocalcemia type 1 (ADH1). A pill that turns down an overactive calcium-sensing receptor, the cause of ADH1. It is under standard review, and the FDA is not planning an advisory committee meeting. BridgeBio says it would be the first therapy approved specifically for ADH1.
What each outcome would mean
An approval starts a second race rather than ending the first one: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. Our guide to the 90 days after a rare disease approval explains the timeline and the moves families can make on day 1.
A complete response letter would mean the FDA declined to approve in the application's current form. CRLs are often about manufacturing or data presentation rather than efficacy, and resubmission is common. Either way, this page updates with the outcome and what it means.
Frequently asked questions
When will the FDA decide on Encaleret?
The FDA's target date (PDUFA date) for Encaleret in Autosomal dominant hypocalcemia type 1 (ADH1) is May 8, 2027.
Who disclosed it: BridgeBio Pharma. The FDA does not publish these dates.
Can it move: the FDA can act early, and a major amendment to the application can push the date back 3 months.
Source: BridgeBio press release
What is Encaleret being reviewed for?
BridgeBio Pharma submitted an NDA for Encaleret in Autosomal dominant hypocalcemia type 1 (ADH1).
What to know: A pill that turns down an overactive calcium-sensing receptor, the cause of ADH1. It is under standard review, and the FDA is not planning an advisory committee meeting. BridgeBio says it would be the first therapy approved specifically for ADH1.
How much will Encaleret cost?
BridgeBio Pharma has not announced a price. Drugmakers usually set it around approval.
Help paying: drugmaker programs and charity funds usually open at launch.
Find help: the patient assistance finder lists programs by insurance type.
What happens after the Encaleret decision?
This page updates with the outcome the day it is announced.
If approved: getting the drug still takes time. Specialty pharmacy setup, insurance review and patient assistance often take weeks. Our guide covers what families can do on day 1.
If not approved: a complete response letter means the FDA declined the application in its current form. Many are about manufacturing or how data were presented, and companies often resubmit.
Where this date comes from
The FDA does not publish PDUFA dates; companies disclose them. This one comes from BridgeBio press release. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified daily.