Parathyroid Hormone (PTH 1-84)
Evidence: B/C — Meaningful Human EvidenceEndocrine / Calcium-Bone Axis Signaling
Evidence Snapshot
What this grade covers
B applies to PTH assay/biomarker physiology and to Natpara's own product-specific REPLACE-trial and regulatory evidence. C applies to any generalized claim that unformulated native PTH itself is a proven therapeutic agent, which no source in this manifest establishes. This grade does not extend Teriparatide's or Yorvipath's own separately-documented evidence to PTH(1-84). Natpara's current commercial availability is not established by any frozen source and must be freshly verified before any public statement of current status.
Regulatory Context
Native PTH(1-84) is an endogenous hormone, not itself a marketed drug. Natpara, an exact-sequence recombinant PTH(1-84) product, was FDA-approved in 2015 for hypoparathyroidism; its current commercial-availability status has not been independently re-verified for this page and must not be assumed. Teriparatide (PTH 1-34) and Yorvipath (a PTH 1-34 prodrug) are separate, fragment-based products.
Research Takeaway
Native intact parathyroid hormone, PTH(1-84), is the 84-amino-acid hormone secreted by the parathyroid glands, distinct from the shorter 34-residue N-terminal fragment (PTH 1-34) used in separate approved products.
Evidence boundary: Fragment-derived products (Teriparatide, Yorvipath) must never be described as full-length PTH(1-84).
See all 5 evidence claims →Quick Summary
Parathyroid Hormone (PTH 1-84) is the body's principal hormone for calcium and phosphate regulation. A recombinant exact-sequence PTH(1-84) product (Natpara) was FDA-approved in 2015 for hypoparathyroidism but has since been discontinued; related fragment-based products (Teriparatide, Yorvipath) are built on a shorter 34-residue piece of the hormone, not the full-length molecule.
Mechanism & Research Overview
Parathyroid Hormone (PTH 1-84) is the body's principal hormone for calcium and phosphate regulation. A recombinant exact-sequence PTH(1-84) product (Natpara) was FDA-approved in 2015 for hypoparathyroidism but has since been discontinued; related fragment-based products (Teriparatide, Yorvipath) are built on a shorter 34-residue piece of the hormone, not the full-length molecule.
Evidence Claims
Individual scientific statements drawn from the sources cited below, each shown with the specific evidence boundary that statement does not establish.
Supported
Native intact parathyroid hormone, PTH(1-84), is the 84-amino-acid hormone secreted by the parathyroid glands, distinct from the shorter 34-residue N-terminal fragment (PTH 1-34) used in separate approved products.
Does not establish
Evidence boundary: Fragment-derived products (Teriparatide, Yorvipath) must never be described as full-length PTH(1-84).
Sources: Cloning and sequence analysis of the human parathyroid hormone gene region
Supported
PTH signals through the PTH1 receptor (PTH1R), a G-protein-coupled receptor also engaged by PTHrP.
Sources: Cloning and functional expression of a human parathyroid hormone receptor
Supported
Second-generation intact-PTH immunoassays can cross-react with inactive C-terminal fragments such as PTH(7-84), complicating result interpretation, particularly in chronic kidney disease.
Sources: Critical issues of PTH assays in CKD
Supported
A recombinant, exact-sequence 84-amino-acid human PTH product (Natpara) was FDA-approved in 2015 as an adjunct to calcium and vitamin D for hypoparathyroidism, based on the placebo-controlled REPLACE trial.
Does not establish
Evidence boundary: This is PRODUCT_SPECIFIC_EVIDENCE for Natpara, not a generalized claim about native PTH's own therapeutic status. Natpara's current commercial availability is not established by any frozen source; verify directly before any public statement of current status.
Sources: Efficacy and safety of recombinant human parathyroid hormone (1-84) in hypoparathyroidism (REPLACE): a double-blind, placebo-controlled, randomised, phase 3 study; NATPARA (parathyroid hormone) for injection — FDA Prescribing Information
Supported
Teriparatide (PTH 1-34) and palopegteriparatide/Yorvipath (a PEGylated PTH(1-34) prodrug that also releases an active PTH(1-33) metabolite, per current labeling) are both built on PTH(1-34)-scale sequence, not full-length PTH(1-84).
Sources: YORVIPATH (palopegteriparatide) injection — FDA Prescribing Information
Safety & Evidence Limitations
Considerations reported in the sources cited on this page — not a complete list of every possible risk, and not medical advice.
Higher-Priority Safety Consideration
Natpara's product labeling carried a boxed warning regarding a potential osteosarcoma risk observed in rat carcinogenicity studies, restricting approved use to patients not adequately controlled on calcium/vitamin D alone. This is a product-specific regulatory finding, not established as a risk of endogenous PTH itself.Safety Consideration
PTH(1-34)-based products (Teriparatide, Yorvipath) are frequently discussed alongside ‘PTH’ generally; their evidence must not be read as evidence about full-length PTH(1-84).Safety Consideration
Second-generation PTH immunoassays can overestimate bioactive PTH by also detecting inactive C-terminal fragments such as PTH(7-84), particularly relevant in chronic kidney disease.
Research Areas Being Studied
Research areas discussed on this page reflect the Endocrine / Calcium-Bone Axis Signaling category and the sources cited below.
Findings Reported in Studies
Educational summary only — reported in cited studies, not a claim of proven benefit.
- Efficacy and safety of recombinant human parathyroid hormone (1-84) in hypoparathyroidism (REPLACE): a double-blind, placebo-controlled, randomised, phase 3 study (2013):
- Cloning and sequence analysis of the human parathyroid hormone gene region (1990):
Study Tables by Evidence Type
Human Studies & Clinical Data
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| Efficacy and safety of recombinant human parathyroid hormone (1-84) in hypoparathyroidism (REPLACE): a double-blind, placebo-controlled, randomised, phase 3 study | 2013 | Adults 18-85y with hypoparathyroidism ≥18 months, 33 sites/8 countries, randomised 2:1 to rhPTH(1-84) 50mcg/day (Natpara) or placebo, 24 weeks | In this Natpara (recombinant human PTH 1-84) product trial (REPLACE), significantly more patients on rhPTH(1-84) achieved the composite primary endpoint (reduced/eliminated oral calcium and active vitamin D while maintaining serum calcium) than on placebo. Product-specific evidence; does not establish that unformulated native PTH(1-84) itself is a proven therapy. | ||
| Cloning and sequence analysis of the human parathyroid hormone gene region | 1990 | Primary cloning and sequence analysis of the human PTH gene region, establishing the gene encoding native intact PTH(1-84). |
Animal / Cell / Preclinical Data
No Animal / Cell / Preclinical Data Listed Yet
This section will be updated as sources are added.
Regulatory Documents & Official Trial Registries
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| NATPARA (parathyroid hormone) for injection — FDA Prescribing Information | Natpara's active ingredient, parathyroid hormone, is produced by recombinant DNA technology using a modified strain of E. coli; it is an 84-amino-acid, 9425-dalton exact-sequence copy of human PTH(1-84). Approved 2015 as an adjunct to calcium and vitamin D for hypocalcemia in hypoparathyroidism, restricted to patients not well-controlled on calcium/vitamin D alone given a labeled potential osteosarcoma risk. Product-specific regulatory evidence; current commercial-availability status must be independently verified before any public statement (governance note, not established by this label alone). | No source link available | |||
| YORVIPATH (palopegteriparatide) injection — FDA Prescribing Information | Palopegteriparatide (Yorvipath) is a prodrug: PTH(1-34) transiently conjugated to a 40 kDa branched methoxy-PEG carrier via a TransCon Linker, which autocleaves to release free PTH(1-34) (plus an active PTH(1-33) metabolite) for continuous exposure via once-daily dosing. FDA-approved 2024 for hypoparathyroidism in adults. This is FRAGMENT_CONTEXT/PRODUCT_SPECIFIC_EVIDENCE relative to native full-length PTH(1-84), not evidence of full-length PTH(1-84) administration. | No source link available |
Review Articles / Secondary Sources
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| Critical issues of PTH assays in CKD | 2009 | Second-generation 'intact PTH' immunoassays cross-react with large PTH fragments retaining a partially preserved N-structure, chiefly PTH(7-84), which are not bioactive at PTH1R; PTH(7-84) can represent >20% of circulating PTH in normal renal function and up to ~45% in renal failure, complicating clinical interpretation, especially in CKD. Review/commentary-tier synthesis, not a new primary cohort. |
Anecdotal Reported Patterns — Not Medical Advice
Anecdotal Reported Patterns — Not Medical Advice
Reported dosing patterns are included for educational context only. They are self-reported, unverified, not medical advice, and not instructions for human use. Community-submitted patterns are not yet available in this Phase 1 prototype; this section is a placeholder reserved for moderated, aggregated community data.
Lab Markers to Discuss With a Clinician
Educational topics only — not self-monitoring instructions.
FAQ
Disclaimer
Educational information only. This page summarizes published research and official regulatory information about Parathyroid Hormone and does not provide medical advice, an individualized treatment recommendation, or dosing instructions.
Educational use only. This content is provided for informational and research-summary purposes only. It is not medical advice, not a treatment recommendation, not a dosing guide, and not a substitute for care from a licensed medical professional. Nothing here is intended to diagnose, treat, cure, prevent, or mitigate disease. Reported dosing patterns, when shown elsewhere on the site, must be labeled either as Study / Trial Dosing or Anecdotal Reported Patterns — Not Medical Advice. Community reports are self-reported, unverified, and not scientific proof.
Community-reported experiences, once enabled, must be displayed only as moderated, anonymized, or aggregated data. They are anecdotal, self-reported, unverified, and should never be presented as proof of safety, efficacy, or expected results.
Content status: Published. Last updated .
Follow research updates for Parathyroid Hormone (PTH 1-84)
Get notified in your MitoCore account when this profile is updated, a new study is added, or its evidence grade changes.
Get updates when new studies or safety notes are added for this peptide.
Get educational updates on new studies, evidence-grade changes, and safety notes. Educational content only — not medical advice.