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  1. pharmadog
  2. ›drugs
  3. ›Yorvipath
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palopegteriparatide

Marketedupdated 3mo ago
by Ascendis Pharma Inc
Approved
community read0 votes

🐶 often sniffed alongside

top 4
  • tagApproval8 co-mentions · 2 sources
  • drugYORVIPATH8 co-mentions · 2 sources
  • companyAscendis Pharma Inc4 co-mentions · 2 sources
  • tagOrthopedics4 co-mentions · 2 sources

Protein drug with a maximum clinical stage of Approval, with an approval for hypoparathyroidism.

all catalysts(2)

approval · 2
Aug 9, 2024
approval
$ASND252.05-0.94%
2y ago
YORVIPATH (PALOPEGTERIPARATIDE) — FDA approval
palopegteriparatide
→
Oct 16, 2025
approval
$ASND252.05-0.94%
10mo ago
YORVIPATH (PALOPEGTERIPARATIDE) — FDA approval
palopegteriparatide
→

Trials studying palopegteriparatide

  • phase3A Study to Test the Effects and Safety of Palopegteriparatide in Adolescents With Long-term Hypoparathyroidismrecruitingn=12
  • phase3A Phase 3 Randomized Clinical Trial to Investigate the Safety and Efficacy of Palopegteriparatide at Doses Greater Than 30 μg/Day in Adult Participants With Hypoparathyroidismrecruitingn=36
  • —A Study to Assess the Amount of Palopegteriparatide in Breast Milk of Lactating Females Requiring YORVIPATH® (Palopegteriparatide)recruitingn=10
  • —A Global Pregnancy Registry to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to YORVIPATH® (Palopegteriparatide) During Pregnancy and Breastfeedingrecruitingn=50
  • —Expanded Access Program of Palopegteriparatide in Patients With Hypoparathyroidismapproved for marketing

Patent cliff

source: FDA Orange Book
first barrier falls
Aug 9, 2029
~3.0 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (27)

  • Nov 12, 2042formulationUS 12403182
  • Nov 12, 2042formulationUS 12403182
  • Nov 12, 2042formulationUS 12403182
  • Sep 28, 2037method-of-use (U-3982)US 11590207
  • Sep 28, 2037method-of-use (U-3982)US 11590207
  • Sep 28, 2037method-of-use (U-3982)US 11590207
  • Sep 28, 2037formulationUS 11759504
  • Sep 28, 2037formulationUS 11759504
  • Sep 28, 2037formulationUS 11759504
  • Sep 28, 2037method-of-use (U-3982)US 11857603
  • Sep 28, 2037method-of-use (U-3982)US 11857603
  • Sep 28, 2037method-of-use (U-3982)US 11857603
  • Sep 28, 2037compositionUS 11890326
  • Sep 28, 2037compositionUS 11890326
  • Sep 28, 2037compositionUS 11890326
  • Sep 28, 2037compositionUS 11918628
  • Sep 28, 2037compositionUS 11918628
  • Sep 28, 2037compositionUS 11918628
  • Sep 28, 2037method-of-use (U-3982)US 12295989
  • Sep 28, 2037method-of-use (U-3982)US 12295989
  • Sep 28, 2037method-of-use (U-3982)US 12295989
  • Sep 28, 2037method-of-use (U-3982)US 12453778
  • Sep 28, 2037method-of-use (U-3982)US 12453778
  • Sep 28, 2037method-of-use (U-3982)US 12453778
  • Apr 30, 2031compositionUS 89068474.7y
  • Apr 30, 2031compositionUS 89068474.7y
  • Apr 30, 2031compositionUS 89068474.7y

FDA exclusivities (6)

  • Aug 9, 2031ODE-492Orphan Drug (7y)5.0y
  • Aug 9, 2031ODE-492Orphan Drug (7y)5.0y
  • Aug 9, 2031ODE-492Orphan Drug (7y)5.0y
  • Aug 9, 2029NCENew Chemical Entity (5y)3.0y
  • Aug 9, 2029NCENew Chemical Entity (5y)3.0y
  • Aug 9, 2029NCENew Chemical Entity (5y)3.0y

News(0)

no news has mentioned this drug yet

brand
Yorvipath
generic
palopegteriparatide
MOA
12.1 Mechanism of Action At physiological conditions, palopegteriparatide releases PTH(1-34) to maintain a continuous systemic exposure. Endogenous PTH maintains extracellular calcium and phosphate homeostasis by increasing serum calcium and decreasing serum phosphate. These effects are mediated by stimulating bone turnover to mobilize calcium and phosphate from bone, promoting renal calcium reabsorption and phosphate excretion, and facilitating active vitamin D synthesis, in turn increasing intestinal absorption of calcium and phosphate. Similar to endogenous PTH, PTH(1-34) released from palopegteriparatide exerts these effects through its main receptor, parathyroid hormone 1 receptor (PTH1R), which is highly expressed on osteoblasts, osteocytes, renal tubular cells, and in several other tissues.
indication
Hypoparathyroidism
phase
marketed
Data sources
openFDA · ClinicalTrials.gov
last refreshed 7m ago
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