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Last update 20 Oct 2026
Canvuparatide
Last update 20 Oct 2026
Overview
Basic Info
Drug Type Small molecule drug, Peptides |
Synonyms MBX 2109, MBX-2109, MBX2109 |
Target |
Action agonists |
Mechanism PTH1R agonists(Parathyroid hormone receptor agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization- |
Drug Highest PhasePhase 3 |
First Approval Date- |
RegulationOrphan Drug (United States), Orphan Drug (European Union) |
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Structure/Sequence
Sequence Code 28596476
Source: *****
Related
5
Clinical Trials associated with CanvuparatideNCT07699471
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Followed by an Open-Label Extension to Evaluate the Safety and Efficacy of Canvuparatide (MBX 2109) in Adult Patients With Hypoparathyroidism
NCT06531941
An Extension Study to Evaluate the Long-Term Safety and Tolerability of MBX 2109 in Patients With Hypoparathyroidism Who Completed the 12-Week Treatment Period in the Phase 2 Study, MBX-2H1002 Study (Avail-Ext)
NCT06465108
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate the Safety, Pharmacokinetics, and Efficacy of MBX 2109 in Patients With Hypoparathyroidism (Avail Study)
100 Clinical Results associated with Canvuparatide
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100 Translational Medicine associated with Canvuparatide
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100 Patents (Medical) associated with Canvuparatide
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2
Literatures (Medical) associated with Canvuparatide01 May 2026Molecular Metabolism
Discovery and characterization of canvuparatide, a once-weekly parathyroid hormone analog for the treatment of hypoparathyroidism
Article
Author: Metzger, Corinne E ; Geiger, Mary Jane ; DiMarchi, Richard D ; Zhang, Fa ; Perez-Tilve, Diego ; Dorato, Michael A ; Allen, Matthew R
Hypoparathyroidism is a rare endocrine disorder characterized by hypocalcemia, hyperphosphatemia, and low or undetectable levels of parathyroid hormone (PTH). Advanced treatments that precisely maintain blood calcium levels within the normal range to improve disease symptoms and outcomes are needed. Canvuparatide (formerly known as MBX 2109) is a once-weekly investigational PTH analog that undergoes a controlled-release conversion to a biologically active peptide through an intramolecular cyclization reaction controlled by temperature and pH. Here we demonstrate the biologically active PTH analog, derived from the canvuparatide prodrug, stimulated dose-dependent accumulation of cyclic AMP to a similar degree and selectivity as a synthetic form of the human PTH(1-34) peptide in human cells overexpressing the PTH type 1 receptor. In healthy rats treated with canvuparatide at 4-40 nmol/kg/day for 28 days and healthy cynomolgus monkeys treated with single doses of canvuparatide 3.75-7.5 nmol/kg, prodrug and active peptide concentrations increased dose proportionally and correlated with increases in serum calcium concentrations. In parathyroidectomized rats, canvuparatide treatment at 10-40 nmol/kg normalized serum calcium levels and increased bone formation in a dose-proportional manner. In a phase 1, randomized, placebo-controlled study (NCT05158335), single subcutaneously administered doses of canvuparatide (50-600 μg) were well tolerated in healthy volunteers. Pharmacokinetic clinical profiles displayed geometric mean t1/2 values of 81-101 (canvuparatide prodrug) and 133-186 h (canvuparatide active peptide) across dose groups, supporting once-weekly dosing. These collective findings support clinical advancement of once-weekly canvuparatide therapy for patients with hypoparathyroidism.
17 Mar 2025JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM
MBX 2109, A Once-Weekly Parathyroid Hormone Replacement Therapy Prodrug: Phase 1, First-In-Human, Randomized Trial
Article
Author: Fa Zhang ; Patricia Carney ; Richard DiMarchi ; Gordon B Cutler ; Kristi Schneider
Abstract:
Context:
Hypoparathyroidism denotes parathyroid hormone (PTH) deficiency and impaired mineral metabolism. MBX 2109, a novel prodrug yielding a biologically active PTH peptide agonist (PTH[1-32], extended by a fatty acylated Lys33), is being developed as a long-acting, once-weekly PTH replacement therapy.
Objective:
Here, we report the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of MBX 2109 in healthy volunteers.
Methods:
This phase 1, randomized, double-blind, placebo-controlled, multiple ascending-dose study (NCT05158335) enrolled healthy adults, who were randomly assigned 4:1 to receive MBX 2109 (200, 400, 600, and 900 μg; n = 8) or placebo (n = 2) by subcutaneous administration once weekly for 4 doses (days 1, 8, 15, and 22). The primary end point was safety and tolerability. Key secondary end points were PK and PD.
Results:
Overall, 40 participants (MBX 2109 n = 32, placebo n = 8) were randomly assigned (mean age, 43.3 years; 22.5% female). Treatment-emergent adverse events (TEAEs) occurred in 50% to 88% of MBX 2109 groups and in 25% of placebo participants. In the MBX 2109 groups, no severe or serious TEAEs were observed. Injection-site reaction was the most common treatment-related TEAE. The half-lives were 79 to 95 hours for MBX 2109 and 184 to 213 hours for the fatty-acylated biologically active PTH peptide, which showed dose- and time-dependent exposure increases.
Conclusion:
The sustained-action PTH prodrug MBX 2109 was well tolerated with no unexpected, off-target safety issues. The long half-life and flat exposure profile of MBX 2109's biologically active PTH agonist supports once-weekly administration. MBX 2109 doses were identified for future studies.
82
News (Medical) associated with Canvuparatide100 Deals associated with Canvuparatide
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External Link
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D13215 | - | - | - |
R&D Status
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Hypoparathyroidism | Phase 3 | United States | 26 Aug 2026 | |
| Hypoparathyroidism | Phase 3 | Canada | 26 Aug 2026 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
Phase 2 | 64 | uxhysjlteb(euikhckixs) = Most common AEs (canvuparatide vs PBO) were headache (20.8% vs 6.3%), hypercalcemia (18.8% vs 6.3%), arthralgia (14.6% vs 0%), and nausea (12.5% vs 6.3%). zkufnetupu (gvoeaxslly ) View more | Positive | 13 Jun 2026 | |||
Placebo | |||||||
Phase 2 | 64 | zxmlubpphv(bblvevfjgz) = lmblqzafuw xrcgdgovac (aqzalscyfh ) View more | Positive | 23 Sep 2025 | |||
| Placebo | zxmlubpphv(bblvevfjgz) = grxbqnuwyf xrcgdgovac (aqzalscyfh ) View more | ||||||
NCT05158335 (Pubmed) Manual  | Phase 1 | 40 | ngxiqftliw(asskzdgiiz) = bsuqbnfxsr zgnzptrync (zvkpaowtea ) View more | Positive | 22 Nov 2024 | ||
Placebo | ngxiqftliw(asskzdgiiz) = chuhljbpio zgnzptrync (zvkpaowtea ) | ||||||
NCT05158335 (NEWS) Manual | Phase 1 | - | 76 | fitdnzvhej(ewzktwbpyg) = the majority of treatment emergent adverse events were mild in severity. No MBX 2109 dose-related serious or severe adverse events, or deaths were observed viellwuxuq (uumoeljepy ) | Positive | 16 Oct 2023 | |
placebo |
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