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Disease
Hyperparathyroidism, Primary
Late-stage therapeutic developmentEmerging research
1
Publications
5
Clinical trials
2022
Latest publication
Latest activity
betaRecent clinical, regulatory, research and industry developments relating to this disease.
Research2022-10-17Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research
What's happening now
An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.
Executive briefingUpdating summary…Momentum: Low
Key developments
- 1 safety action from EMA issued.
- 1 clinical trial with recent milestones (1 completed or reporting results).
Major developments
Major safety communicationImportant
Secondary hyperparathyroidism Adults Treatment of secondary hyperparathyroidism (HPT) in adult patients with end stage renal disease (ESRD) on maintenance dialysis therapy. Paediatric population Treatment of secondary hyperparathyroidism (HPT) in children aged 3 years and older with end stage renal disease (ESRD) on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy. Mimpara may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate. Parathyroid carcinoma and primary hyperparathyroidism in adults. Reduction of hypercalcaemia in adult patients with: parathyroid carcinoma; primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.2025-12-18
Clinical milestoneWorth watching
Completed2025-12-31
Clinical MilestonesViewHide
Recently completed
Regulatory UpdatesViewHide
- 2025-12-18Market withdrawal — Cinacalcet hydrochlorideSecondary hyperparathyroidism Adults Treatment of secondary hyperparathyroidism (HPT) in adult patients with end stage renal disease (ESRD) on maintenance dialysis therapy. Paediatric population Treatment of secondary hyperparathyroidism (HPT) in children aged 3 years and older with end stage renal disease (ESRD) on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy. Mimpara may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate. Parathyroid carcinoma and primary hyperparathyroidism in adults. Reduction of hypercalcaemia in adult patients with: parathyroid carcinoma; primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.
Activity timeline2
- 2025-12-31Clinical18F-Fluorocholine Positron Emission Tomography (PET) for the Detection of Parathyroid AdenomasCompleted
- 2025-12-18RegulatoryMarket withdrawal — Cinacalcet hydrochlorideSecondary hyperparathyroidism Adults Treatment of secondary hyperparathyroidism (HPT) in adult patients with end stage renal disease (ESRD) on maintenance dialysis therapy. Paediatric population Treatment of secondary hyperparathyroidism (HPT) in children aged 3 years and older with end stage renal disease (ESRD) on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy. Mimpara may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate. Parathyroid carcinoma and primary hyperparathyroidism in adults. Reduction of hypercalcaemia in adult patients with: parathyroid carcinoma; primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.
Therapeutic landscape
Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.
Approved & established therapies
Cinacalcet hydrochlorideapproved
Approval — Secondary hyperparathyroidism AdultsTreatment of secondary hyperparathyroidism (HPT) in a… (2020)
Clinical trials
The current development programme across all trial phases.
Clinical programme
5
0
3
5
Late-stage studies
Recently completed
Regulatory timeline
Drug regulatory events matched to this condition by indication — EMA.
First approvals
2020emaApproval — Cinacalcet hydrochloride· Secondary hyperparathyroidism AdultsTreatment of secondary hyperparathyroidism (HPT) in adult patients with end-stage renal disease (ESRD) on maintenance dialysis therapy. Paediatric populationTreatment of secondary hyperparathyroidism (HPT) in children aged 3 years and older with end-stage renal disease (ESRD) on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy (see section 4.4). Cinacalcet Accordpharma may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate (see section 5.1). Parathyroid carcinoma and primary hyperparathyroidism in adults Reduction of hypercalcaemia in adult patients with: parathyroid carcinoma. primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated. source ↗
2015emaApproval — Cinacalcet hydrochloride· Treatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on maintenance dialysis therapy. Cinacalcet Mylan may be used as part of a therapeutic regimen including phosphate binders and/or vitamin D sterols, as appropriate. Reduction of hypercalcaemia in patients with: parathyroid carcinoma primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated. source ↗
Safety updates
2025emaMarket withdrawal — Cinacalcet hydrochloride· Secondary hyperparathyroidism Adults Treatment of secondary hyperparathyroidism (HPT) in adult patients with end stage renal disease (ESRD) on maintenance dialysis therapy. Paediatric population Treatment of secondary hyperparathyroidism (HPT) in children aged 3 years and older with end stage renal disease (ESRD) on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy. Mimpara may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate. Parathyroid carcinoma and primary hyperparathyroidism in adults. Reduction of hypercalcaemia in adult patients with: parathyroid carcinoma; primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated. source ↗
European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.
Research activity
Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.
Most influential
Major themes1
- Hyperparathyroidism, Primary1
Leading journals1
- Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research1
Leading researchers8
- Bilezikian JP1
- Brandi ML1
- Clarke BL1
- Fuleihan GE1
- Guyatt G1
- Khan AA1
- Mannstadt M1
- Marcocci C1
Affiliations (unnormalised)6
- American University of Beirut1
- Department of Clinical1
- Department of Clinical and Experimental Medicine1
- Fondazione Italiana sulla Ricerca sulle Malattie dell'Osso (F.I.R.M.O. Foundation)1
- Massachusetts General Hospital and Harvard Medical School1
- Mayo Clinic Division of Endocrinology1
Reference
Authoritative identity, definition & identifiers.
Defined in MeSH
A condition of abnormally elevated output of PARATHYROID HORMONE due to parathyroid HYPERPLASIA or PARATHYROID NEOPLASMS. It is characterized by the combination of HYPERCALCEMIA, phosphaturia, elevated renal 1,25-DIHYDROXYVITAMIN D3 synthesis, and increased BONE RESORPTION.
Identifiers
References & data sources
- Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
- Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
- Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
- Related entities are derived from literature co-mention (studied together) — associative, not causal.