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Disease

Secondary hyperparathyroidism

Late-stage therapeutic development

Also known as secondary hyperparathyroidism (disease), secondary hyperparathyroidism NOS.

16
Clinical trials
1
Associated genes
1
Related proteins
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this disease.

Market withdrawal: Mimpara (EMA)

Regulatory2025-12-18EMA

What's happening now

An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.

Executive briefingUpdating summary…Momentum: Moderate
Key developments
  • 3 clinical trials expected to report results, the earliest in Q4 2026.
  • 1 safety action from EMA issued.
Upcoming Milestones
Major developments
Upcoming trial readoutHigh impact
Phase 3, Single-arm, Open-label, Multidose, Titration, Pharmacokinetic, Pharmacodynamic, and Safety Study of Etelcalcetide in Children and Adolescents ≥ 2 to < 18 Years of Age With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis
Results expected Q2 20272026-03-23
Upcoming trial readoutImportant
Phase 3, Randomized, Open-label, Controlled, Multiple Dose, Efficacy, Safety, Pharmacokinetic, and Pharmacodynamic Study of Etelcalcetide in Pediatric Subjects 28 Days to < 18 Years of Age With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis
Results expected Q1 20292026-02-27
Major safety communicationImportant
Market 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.2025-12-18
Clinical Milestones4View
Results expected 3
Recently completed 1
Regulatory Updates1View
  • 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 timeline5

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)

Etelcalcetide hydrochlorideapproved

Approval — Parsabiv is indicated for the treatment of secondary hyperparathyroidism (SHPT) in adult… (2016)

Clinical trials

12 sponsors · 1 new · 1 completed in the last 12 months (net +1)

The current development programme across all trial phases.

Clinical programme
16
All trials
4
Active
14
Late-stage
6
Completed
Late-stage studies

Phase 3, Randomized, Open-label, Controlled, Multiple Dose, Efficacy, Safety, Pharmacokinetic, and Pharmacodynamic Study of Etelcalcetide in Pediatric Subjects 28 Days to < 18 Years of Age With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis

Phase 3 · Recruiting · Amgen

Phase 3, Single-arm, Open-label, Multidose, Titration, Pharmacokinetic, Pharmacodynamic, and Safety Study of Etelcalcetide in Children and Adolescents ≥ 2 to < 18 Years of Age With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis

Phase 3 · Recruiting · Amgen

A Multicenter, Randomized, Double-blind, Double-dummy, Phase III Study to Evaluate the Efficacy and Safety of MT1013 Versus Cinacalcet as Active Control in Secondary Hyperparathyroidism Patients on Maintenance Dialysis

Phase 3 · Recruiting · Shaanxi Micot Pharmaceutical Technology Co., Ltd.

Comparison of Medical Therapy (Oral Cinacalcet) Versus Surgical Therapy (Total Parathyroidectomy) on Vascular/Valvular Calcification in Chronic Peritoneal Dialysis Patients With Secondary Hyperparathyroidism - A Pilot Randomized Study

Phase 4 · Completed · The University of Hong Kong

A Multicenter, Randomised, Double-blind, Double-dummy Study to Assess the Efficacy and Safety of SHR6508 in Hemodialysis Subjects With Secondary Hyperparathyroidism

Phase 3 · Completed · Shanghai Hengrui Pharmaceutical Co., Ltd.

A Prospective, Non-randomised, Single-arm, Open-Label Pilot Clinical Study Evaluating the Effect of PTH Lowering on Erythropoietin Consumption in Calcitriol-Resistant Patients

Phase 4 · Completed · AbbVie (prior sponsor, Abbott)
Recruiting

Phase 3, Randomized, Open-label, Controlled, Multiple Dose, Efficacy, Safety, Pharmacokinetic, and Pharmacodynamic Study of Etelcalcetide in Pediatric Subjects 28 Days to < 18 Years of Age With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis

Phase 3 · Recruiting · Amgen

Phase 3, Single-arm, Open-label, Multidose, Titration, Pharmacokinetic, Pharmacodynamic, and Safety Study of Etelcalcetide in Children and Adolescents ≥ 2 to < 18 Years of Age With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis

Phase 3 · Recruiting · Amgen

A Multicenter, Randomized, Double-blind, Double-dummy, Phase III Study to Evaluate the Efficacy and Safety of MT1013 Versus Cinacalcet as Active Control in Secondary Hyperparathyroidism Patients on Maintenance Dialysis

Phase 3 · Recruiting · Shaanxi Micot Pharmaceutical Technology Co., Ltd.

A Multi-center, Open, Single-arm Phase IIb Clinical Study to Evaluate the Safety and Efficacy of MT1013 Injection for the Treatment of Secondary Hyperparathyroidism (SHPT) Patients With Chronic Kidney Disease Undergoing Maintenance Dialysis

Phase 2 · Recruiting · Shaanxi Micot Pharmaceutical Technology Co., Ltd.
Recently completed

A Multicenter, Randomised, Double-blind, Double-dummy Study to Assess the Efficacy and Safety of SHR6508 in Hemodialysis Subjects With Secondary Hyperparathyroidism

Phase 3 · Completed · Shanghai Hengrui Pharmaceutical Co., Ltd.

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Dose-Titrated PLS240 in the Treatment of Secondary Hyperparathyroidism in Individuals With End Stage Kidney Disease on Hemodialysis (PATH-2) With an Open-Label Extension

Phase 3 · Completed · Pathalys Pharma

The Effect of Teriparatide on the Early Postoperative Hypocalcemia After Parathyroidectomy in Dialysis Patients: a Pilot, Randomized Trial

Phase 3 · Completed · Saint Petersburg State University, Russia

A Phase 3, Randomized, Double-Blind, Intra-Subject Dose-Adjustment, Parallel-Group Study of KHK7580 and Cinacalcet Hydrochloride in Subjects With Secondary Hyperparathyroidism Receiving Hemodialysis

Phase 3 · Completed · Kyowa Kirin Co., Ltd.

Comparison of Medical Therapy (Oral Cinacalcet) Versus Surgical Therapy (Total Parathyroidectomy) on Vascular/Valvular Calcification in Chronic Peritoneal Dialysis Patients With Secondary Hyperparathyroidism - A Pilot Randomized Study

Phase 4 · Completed · The University of Hong Kong

A Prospective, Non-randomised, Single-arm, Open-Label Pilot Clinical Study Evaluating the Effect of PTH Lowering on Erythropoietin Consumption in Calcitriol-Resistant Patients

Phase 4 · Completed · AbbVie (prior sponsor, Abbott)

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 ↗
2016emaApproval — Etelcalcetide hydrochloride· Parsabiv is indicated for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on haemodialysis therapy. 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.

Associated genes

1 match

Genes associated with this disease in the canonical knowledge graph (Open Targets evidence). Number shows the association score.

VDR0.60

Disease biology

1 match

Proteins whose encoding gene is associated with this disease, reached through the canonical gene→disease graph. Number shows the gene's association score.

Vitamin D3 receptorvia VDR0.60

Reference

Authoritative identity, definition & identifiers.

Synonyms

secondary hyperparathyroidism (disease), secondary hyperparathyroidism NOS

References & data sources
  • Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
  • Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
  • Related entities are derived from literature co-mention (studied together) — associative, not causal.