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Related Concept Videos

The Parathyroid Glands00:59

The Parathyroid Glands

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The two pairs of parathyroid glands embedded within the posterior surface of the thyroid gland are restricted by a dense capsule around them. These glands comprise two distinct cell populations—parathyroid oxyphil and parathyroid principal cells- pivotal in calcium homeostasis.
Oxyphil cells, whose functions remain elusive, emerge during late puberty, adding a layer of complexity to the parathyroid gland's intricacies. In contrast, principal parathyroid cells undertake a vital role by...
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Receptor tyrosine kinase inhibitors (TKIs) and calcium channel blockers (CCBs) are two critical categories of drugs employed in the treatment of pulmonary artery hypertension (PAH). PAH is a disease that causes high blood pressure in the pulmonary arteries, resulting in chest pain, fatigue, and shortness of breath.
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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Related Experiment Video

Updated: Jun 6, 2025

Generation of Hypoparathyroid Rats via Carbon-Nanoparticle-Assisted Parathyroidectomy
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MBX 2109, A Once-Weekly Parathyroid Hormone Replacement Therapy Prodrug: Phase 1, First-In-Human, Randomized Trial.

Patricia Carney1, Gordon B Cutler2, Kristi Schneider3

  • 1Clinical Operations, MBX Biosciences Inc, Carmel, IN 46032, USA.

The Journal of Clinical Endocrinology and Metabolism
|November 22, 2024
PubMed
Summary

MBX 2109, a novel parathyroid hormone (PTH) prodrug, demonstrated good tolerability in healthy volunteers. Its long half-life supports a convenient once-weekly dosing regimen for potential PTH replacement therapy.

Keywords:
hormone replacement therapyhypocalcemiahypoparathyroidismparathyroid hormonepeptide therapeuticsprodrug

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Area of Science:

  • Endocrinology
  • Pharmacology

Background:

  • Hypoparathyroidism is characterized by parathyroid hormone (PTH) deficiency, leading to impaired mineral metabolism.
  • MBX 2109 is a novel prodrug designed for long-acting, once-weekly PTH replacement therapy.

Purpose of the Study:

  • To evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of MBX 2109 in healthy volunteers.

Main Methods:

  • A phase 1, randomized, double-blind, placebo-controlled study involving multiple ascending doses of MBX 2109 administered subcutaneously once weekly for four doses.
  • Participants were assigned to receive MBX 2109 (200-900 mcg) or placebo in a 4:1 ratio.

Main Results:

  • MBX 2109 was generally well-tolerated, with no severe or serious treatment-emergent adverse events (TEAEs) reported.
  • Injection-site reactions were the most frequent treatment-related TEAE.
  • The active PTH peptide demonstrated dose- and time-dependent exposure with half-lives of 79-95 hours for MBX 2109 and 184-213 hours for the active peptide.

Conclusions:

  • MBX 2109, a sustained-action PTH prodrug, exhibited favorable safety and tolerability without unexpected off-target effects.
  • The long half-life and consistent exposure profile of its active PTH agonist support a once-weekly administration schedule.
  • Doses for future clinical studies with MBX 2109 were identified.