(Albany, US) On November 09, 2026, DelveInsight’s Hypoparathyroidism market report provides comprehensive insights into the Hypoparathyroidism market and pipeline landscape across the 7MM. It covers marketed and emerging drug profiles, including late-stage products. It also covers the therapeutics assessment by mechanism, molecule type, and designation, and examines the market drivers and barriers shaping the space.

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Key Takeaways from the Hypoparathyroidism Report

• In March 2025, the Phase III CALYPSO trial showed that eneboparatide (AZP-3601), an investigational PTH receptor 1 agonist, met its primary endpoint at 24 weeks in adults with chronic hypoparathyroidism, outperforming placebo. The primary endpoint included normalization of serum calcium and independence from active vitamin D and calcium therapy.

• In September 2024, Ascendis Pharma announced that the FDA granted seven years of Orphan Drug exclusivity to YORVIPATH (palopegteriparatide, TransCon PTH) for adults with hypoparathyroidism, which affects about 70,000 to 90,000 people in the US.

• The hypoparathyroidism market in the 7MM was about USD 370 million in 2023, with the US at about USD 200 million, or roughly 60% of the total.

• NATPARA was recalled by Takeda in 2019 and was planned for global discontinuation at the end of 2024.

• US prevalence is estimated at 24 to 37 per 100,000, and chronic hypoparathyroidism accounts for nearly 90% of cases.

• DelveInsight’s report depicts a space moving from calcium and vitamin D toward PTH replacement and novel mechanisms such as PTHR1 agonism and calcium-sensing receptor antagonism.

• Leading Hypoparathyroidism companies include Ascendis Pharma, Amolyt Pharma, BridgeBio, Calcilytix Therapeutics, and others.

• Promising therapies include TransCon PTH (palopegteriparatide), eneboparatide (AZP-3601), encaleret (BBP-305/CLTX-305), and others.

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Hypoparathyroidism Overview

Hypoparathyroidism is a rare endocrine disease in which the parathyroid glands fail to make enough parathyroid hormone (PTH), or the hormone lacks activity. It is marked by low serum calcium, high serum phosphorus, and absent or inappropriately low PTH. Most cases follow neck surgery such as thyroidectomy, while other causes include genetic conditions, autoimmune destruction, radiation, and magnesium depletion. Diagnosis relies on albumin-corrected calcium, PTH (preferably second- or third-generation assays), magnesium, and 25-hydroxyvitamin D. Standard care aims to keep calcium in the low-normal range using oral calcium, active vitamin D analogs, thiazide diuretics when needed for hypercalciuria, and magnesium. Patients hard to control can be treated with daily subcutaneous PTH replacement, which lowers oral calcium and calcitriol needs.

Common features include:

• Low serum calcium and high phosphorus

• Low or inappropriately normal PTH

• Symptoms of hypocalcemia

• Risk of hypercalciuria on treatment

• Female predominance, at about 4:1

Hypoparathyroidism Emerging Drugs Profile

TransCon PTH (Palopegteriparatide): Ascendis Pharma TransCon PTH is a once-daily prodrug of PTH designed to restore physiologic PTH levels, addressing both short-term symptoms and long-term complications. It was studied in the global Phase III PaTHway trial in 76 adults, and the FDA accepted its NDA for Priority Review in October 2022. It is marketed as YORVIPATH and holds Orphan Drug exclusivity.

Eneboparatide (AZP-3601): Amolyt Pharma Eneboparatide is an investigational PTH receptor 1 (PTHR1) agonist for chronic hypoparathyroidism with Orphan Drug Designation. The Phase III CALYPSO trial met its primary endpoint in March 2025. Currently, the drug is in Phase III.

Encaleret (BBP-305/CLTX-305): BridgeBio/Calcilytix Therapeutics Encaleret is an investigational small-molecule calcium-sensing receptor (CaSR) antagonist being studied in autosomal dominant hypocalcemia type 1 (ADH1), a calcium disorder related to hypoparathyroidism. It holds Fast Track and Orphan Drug designations. Currently, the drug is in Phase III.

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Hypoparathyroidism Market Drivers

• Large unmet need: Standard care manages calcium but does not replace missing PTH, leaving demand for better options.

• Novel mechanisms: PTH replacement, PTHR1 agonists, and CaSR antagonists are advancing in late-stage trials.

• Regulatory support: Orphan, Fast Track, and Priority Review designations speed development.

• Positive late-stage data: CALYPSO’s success for eneboparatide and YORVIPATH’s approval show momentum.

• Withdrawal of NATPARA: Its recall and planned discontinuation open room for newer PTH therapies.

• Rising healthcare spending: Greater spending across the 7MM supports adoption of new treatments.

• Strong US market: The US makes up about 60% of the 7MM market.

Learn about new drugs, pipeline developments, and key players with DelveInsight’s expert analysis @ Hypoparathyroidism Market Drivers and Barriers

Hypoparathyroidism Market Barriers

• Rarity: A small patient population limits trial size and commercial scale.

• Established low-cost care: Calcium, vitamin D analogs, and diuretics are inexpensive and widely used.

• High cost of new therapies: Newly authorized drugs are expensive, and some patients use cheaper off-label options.

• Daily injection burden: PTH replacement requires daily subcutaneous dosing.

• Safety and supply history: NATPARA’s recall highlights manufacturing and supply risks.

• Diagnostic nuance: Accurate PTH assays and definition of transient versus permanent disease are needed.

• Reimbursement pressure: Payers weigh price against benefit, and access varies by country.

Scope of the Hypoparathyroidism Report

• Coverage: 7MM (US, EU4, UK, Japan)

• Companies: As listed above

• Therapies: TransCon PTH (palopegteriparatide), eneboparatide (AZP-3601), encaleret (BBP-305/CLTX-305), and others

• Study Period: 2020–2034 (Forecast: 2024–2034)

• Analysis: Epidemiology segmentation, market size by therapy and class, drug uptake, KOL views, SWOT, conjoint analysis, market access and reimbursement, unmet needs

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Table of Contents

1. Introduction

2. Executive Summary

3. Hypoparathyroidism: Overview

4. Pipeline Therapeutics

5. Therapeutic Assessment

6. DelveInsight’s Analytical Perspective

7. Late Stage Products (Phase III): Eneboparatide/AZP-3601 (Amolyt Pharma), Encaleret (BridgeBio/Calcilytix)

8. Mid Stage Products (Phase II): None specified

9. Early Stage Products (Phase I): None specified

10. Preclinical and Discovery Stage Products

11. Inactive Products

12. Key Companies

13. Key Products

14. Unmet Needs

15. Market Drivers and Barriers

16. Future Perspectives and Conclusion

17. Analyst Views

18. Appendix

19. About Us

About DelveInsight DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe.

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