Hypopara Life — Hypoparathyroidism Treatment Pipeline
A living timeline of every major drug development milestone for hypoparathyroidism and ADH1 — from Phase 2 trials to FDA approval and beyond. Click any milestone to read the full article or announcement.
Yorvipath®
Ascendis Pharma · Once-daily injectable PTH analog
Phase 3 PaTHway Trial
Pivotal Phase 3 trial of palopegteriparatide (TransCon PTH) in adults with hypoparathyroidism.
NEJM PaTHway ResultsFDA Approval — First PTH Replacement Therapy
Yorvipath (palopegteriparatide) received FDA approval as the first continuous PTH replacement therapy for adults with hypoparathyroidism. A landmark moment for the community.
Hypopara Life Press ReleaseReal-World Prescribing Begins
Physicians begin prescribing Yorvipath in clinical practice. Early real-world case series presented at AACE 2026 highlight dosing strategies and the importance of close monitoring.
AACE 2026 CoveragePhase 3 Higher-Dose Study (NCT07081997)
Ascendis Pharma initiates a new Phase 3 trial evaluating higher doses of palopegteriparatide for patients who need more aggressive PTH replacement.
Read on News PageEncaleret
BridgeBio Pharma · Oral calcilytic (CaSR antagonist)
Phase 2 Trials in ADH1 & Hypoparathyroidism
BridgeBio demonstrated encaleret's ability to restore mineral homeostasis in ADH1 and showed early signals in chronic hypoparathyroidism.
NEJM Phase 2 ResultsPhase 3 CALIBRATE Trial (ADH1)
Pivotal Phase 3 registrational trial of encaleret in adults with Autosomal Dominant Hypocalcemia Type 1 (ADH1).
CALIBRATE AnnouncementCALIBRATE Primary Results at ECE 2026
Phase 3 CALIBRATE primary results presented at ECE 2026 in Prague. 76% of participants achieved both serum and urine calcium within target ranges at Week 24, vs. 4% on conventional therapy (p<0.0001). All pre-specified primary and key secondary endpoints met.
Read NDA Submission Press ReleaseNDA Submitted to FDA
BridgeBio submitted the NDA to the FDA for encaleret for ADH1 on May 12, 2026. Encaleret may be eligible for priority review. MAA submission to EMA planned for H2 2026.
Read NDA Press ReleaseAnticipated U.S. Launch
BridgeBio anticipates a U.S. commercial launch of encaleret in early 2027, pending FDA approval. This would make encaleret the first therapy specifically approved for ADH1.
Press ReleaseRECLAIM-HP Phase 3 (Chronic Hypoparathyroidism)
BridgeBio plans to initiate RECLAIM-HP, a Phase 3 study of encaleret in chronic hypoparathyroidism — expanding the potential encaleret franchise beyond ADH1.
Press ReleaseCanvuparatide
MBX Biosciences · Once-weekly long-acting PTH analog
Phase 2 Avail™ Trial
MBX Biosciences completed the Phase 2 Avail™ trial of canvuparatide, a once-weekly PTH therapy enabled by the Precision Endocrine Peptide (PEP™) platform.
MBX IR PageSuccessful FDA End-of-Phase 2 Meeting
MBX Biosciences completed a successful End-of-Phase 2 meeting with the FDA, clearing the path toward a Phase 3 registrational trial of canvuparatide.
MBX AnnouncementFull Phase 2 Results & 1-Year OLE Data
MBX plans to present full Phase 2 Avail™ results, including one-year open-label extension (OLE) data for canvuparatide.
Read on News PagePhase 3 Trial Initiation
MBX Biosciences is advancing toward initiation of a Phase 3 registrational trial of once-weekly canvuparatide for hypoparathyroidism.
MBX IR PageEB613
Entera Bio · Oral PTH(1-34) tablet
Phase 2 Multi-Tablet Formulation Studies
Entera Bio evaluated the multi-tablet formulation of EB613 (oral PTH 1-34) in Phase 2 studies for hypoparathyroidism.
Entera Q1 2026 UpdatePhase 1 Bridging Study — Single Tablet Formulation
Entera completed a Phase 1 PK and safety bridging study comparing the single-tablet formulation of EB613 to the multi-tablet formulation and to Forteo® (teriparatide SC injection, Eli Lilly).
Read Full ReleaseEB612 Proof-of-Concept Data Submitted to ENDO2026
PK and TPTX proof-of-concept data for EB612 in hypoparathyroidism submitted as an abstract to ENDO2026. NHP PK data for EB618 also submitted to ENDO2026 and ASBMR.
Entera Q1 2026 UpdatePhase 3 — Single Tablet EB613 as Lead Candidate
Based on the bridging study results, Entera plans to advance the single tablet of EB613 into Phase 3 as the lead candidate — a potential once-daily oral PTH option for hypoparathyroidism.
Read Full ReleaseEneboparatide
Alexion, AstraZeneca Rare Disease · Once-daily injectable PTH1R agonist
AstraZeneca Acquires Amolyt Pharma & Eneboparatide
AstraZeneca acquired Amolyt Pharma, bringing eneboparatide (AZP-3601) — a novel PTH receptor 1 agonist — into the Alexion, AstraZeneca Rare Disease pipeline. Eneboparatide was granted FDA Fast Track and Orphan Drug designation for hypoparathyroidism.
AstraZeneca Acquisition AnnouncementPhase 2 Trial — Proof of Concept
Phase 2 results demonstrated that eneboparatide restored mineral homeostasis in adults with chronic hypoparathyroidism, supporting advancement to Phase 3. 20 µg/day selected as the starting dose.
Phase 2 Results (PMC)CALYPSO Phase 3 — Primary Endpoint Met at 24 Weeks (Interim)
The CALYPSO Phase 3 trial met its primary endpoint at 24 weeks with statistical significance. Eneboparatide significantly normalized albumin-adjusted serum calcium and achieved independence from active vitamin D and oral calcium supplements vs. placebo.
AstraZeneca CALYPSO Press ReleaseCALYPSO Full Results Presented at ECE 2026 — 31.1% Achieved Supplement Independence
Late-breaking full CALYPSO results presented at the European Congress of Endocrinology in Prague. 31.1% of patients treated with eneboparatide achieved normalised serum calcium and independence from active vitamin D and oral calcium supplements at week 24 vs. 5.9% placebo (p=0.0001). Urinary calcium normalised in 56.6% of hypercalciuric patients. Well tolerated over 52 weeks. All key secondary endpoints met.
AstraZeneca CALYPSO Full ResultsRegulatory Submissions (NDA/MAA) Anticipated
Following the positive full CALYPSO dataset, Alexion/AstraZeneca is expected to submit regulatory applications to the FDA and EMA. If approved, eneboparatide would be the second PTH replacement therapy available for hypoparathyroidism in the US.
AstraZeneca CALYPSO Full ResultsEB612
Entera Bio · Oral PTH(1-34) tablet
Preclinical & Animal PK Studies
Entera Bio conducted preclinical pharmacokinetic studies of EB612, an oral PTH(1-34) formulation specifically developed for hypoparathyroidism, in non-human primates (NHP). NHP PK data submitted as an abstract to ENDO2026 and ASBMR.
Entera Q1 2026 UpdateProof-of-Concept Data Submitted to ENDO2026 & ASBMR
Entera submitted PK and TPTX proof-of-concept data for EB612 in hypoparathyroidism to ENDO2026 and ASBMR. Entera CEO Miranda personally confirmed to the Hypopara Life community that EB612 news will be presented at both conferences.
Entera Q1 2026 UpdateEB612 Data Presentations Expected
Entera Bio is expected to present EB612 hypoparathyroidism data at ENDO2026 and ASBMR. These presentations will provide the first public clinical or preclinical data readout for EB612 and could define the path toward Phase 1 trials.
Read on News PagePhase 1 Clinical Trial (Anticipated)
Subject to positive conference data, Entera Bio is expected to advance EB612 into Phase 1 clinical trials in hypoparathyroidism patients. If successful, EB612 could become a second oral PTH option alongside EB613.
Entera Bio WebsiteSEP-479
Septerna · Oral small molecule PTH1R agonist
Initial Phase 1 Safety & Tolerability Study
Septerna completed an initial Phase 1 trial evaluating the safety and tolerability of its oral small molecule PTH1R agonist program. This was the first oral small molecule approach to directly activate the PTH receptor.
HypoParathyroidism NewsPhase 1 SAD/MAD Trial Initiated for SEP-479
In April 2026, Septerna initiated a Phase 1 single-ascending dose (SAD) and multiple-ascending dose (MAD) clinical trial of SEP-479, its potent, selective oral small molecule PTH1R agonist. The study evaluates safety, tolerability, pharmacokinetics and pharmacodynamics (including serum calcium and endogenous PTH) in healthy volunteers.
Globe Newswire - Septerna Q1 2026Phase 1 Data Readout Expected
Septerna expects Phase 1 data from the SEP-479 trial in late 2026 or early 2027. A favorable safety and PK profile would support advancement toward Phase 2 efficacy studies. SEP-479 is backed by a $522M cash runway extending at least into 2029.
Globe Newswire - Septerna Q1 2026