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rhPTH (1-84)
rhPTH (1-84) is a PTH1 receptor agonist Biologic drug developed by Shire. It is currently FDA-approved for Hypoparathyroidism.
rhPTH (1-84) is a recombinant human parathyroid hormone that binds to PTH1 receptors on bone cells to stimulate bone formation and increase serum calcium and phosphate levels.
RhPTH (1-84) is a parathyroid hormone receptor agonist used to treat conditions such as hypoparathyroidism, chronic hypoparathyroidism, and osteoporosis. It is a protein-based drug that acts on the parathyroid hormone/parathyroid hormone-related peptide receptor.
At a glance
| Generic name | rhPTH (1-84) |
|---|---|
| Sponsor | Shire |
| Drug class | PTH1 receptor agonist |
| Target | PTH1 receptor |
| Modality | Biologic |
| Therapeutic area | Endocrinology |
| Phase | FDA-approved |
Mechanism of action
rhPTH (1-84) is the full-length recombinant parathyroid hormone that activates PTH1 receptors on osteoblasts and osteocytes, promoting bone anabolism and increasing bone mineral density. It also enhances renal reabsorption of calcium and stimulates phosphate excretion, thereby normalizing mineral homeostasis. This mechanism makes it effective for treating hypoparathyroidism by replacing deficient endogenous PTH.
Approved indications
- Hypoparathyroidism
Common side effects
- Hypercalcemia
- Hyperphosphatemia
- Headache
- Nausea
- Injection site reactions
Key clinical trials
- Palopegteriparatide in Chronic Hypoparathyroidism
- A Registry for Participants With Chronic Hypoparathyroidism
- HEXT (Hypo EXTended): Effect of PTH on Skeleton in Hypoparathyroidism (PHASE3)
- A Study of Relative Bioavailability of a New Formulation Compared With the Approved Formulation of rhPTH [1-84] and to Find Out Dose Linearity of the New Formulation in Healthy Adults (PHASE1)
- A Study to Learn if Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Can Improve Symptoms and Metabolic Control in Adults With Hypoparathyroidism (BALANCE) (PHASE4)
- A Clinical Study of rhPTH(1-84) Treatment in Japanese Participants With Chronic Hypoparathyroidism (PHASE3)
- Safety and Efficacy Study of rhPTH(1-84) in Subjects With Hypoparathyroidism (PHASE3)
- A Study of Extended Use of Recombinant Human Parathyroid Hormone (rhPTH(1-84)) in Hypoparathyroidism (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- rhPTH (1-84) CI brief — competitive landscape report
- rhPTH (1-84) updates RSS · CI watch RSS
- Shire portfolio CI
Frequently asked questions about rhPTH (1-84)
What is rhPTH (1-84)?
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Related
- Drug class: All PTH1 receptor agonist drugs
- Target: All drugs targeting PTH1 receptor
- Manufacturer: Shire — full pipeline
- Therapeutic area: All drugs in Endocrinology
- Indication: Drugs for Hypoparathyroidism
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing