Palopegteriparatide ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
235副甲状腺機能低下症4

235. 副甲状腺機能低下症


臨床試験数 : 88 薬物数 : 107 - (DrugBank : 24) / 標的遺伝子数 : 5 - 標的パスウェイ数 : 7
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05654701
(ClinicalTrials.gov)
March 20238/12/2022Expanded Access Program of Palopegteriparatide in Patients With HypoparathyroidismExpanded Access Program of Palopegteriparatide in Patients With HypoparathyroidismHypoparathyroidismDrug: Palopegteriparatide (TransCon PTH)Ascendis Pharma Bone Diseases A/SNULLAvailable18 YearsN/AAllNULL
2EUCTR2020-003380-26-DE
(EUCTR)
25/02/202102/11/2020PaTHway TRIAL: A Clinical Trial to Investigate the Safety and Effectiveness of TransCon PTH Administered as an Injection Under the Skin in Adults with Hypoparathyroidism.A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial, with an Open-Label Extension, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Adults with Hypoparathyroidism Hypoparathyroidism in Adults
MedDRA version: 20.0;Level: PT;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: TransCon PTH low-dose pen
INN or Proposed INN: Palopegteriparatide
Other descriptive name: POLY(OXY-1,2-ETHANEDIYL), ALPHA-HYDRO-OMEGA-METHOXY, ETHER WITH N-[[[2-[[6-[[1-[3-[[3-(2,3-DIHYDROXYPROPOXY)PROPYL]AMINO]-3-OXOPROPYL]-2,5-DIOXO-3-PYRROLIDINYL]THIO]HEXYL]AMINO]ETHYL]AMINO]CARBONYL]-2-METHYLALANYL-TERIPARATIDE (2:1)
Product Name: TransCon PTH mid-dose pen
INN or Proposed INN: Palopegteriparatide
Other descriptive name: POLY(OXY-1,2-ETHANEDIYL), ALPHA-HYDRO-OMEGA-METHOXY, ETHER WITH N-[[[2-[[6-[[1-[3-[[3-(2,3-DIHYDROXYPROPOXY)PROPYL]AMINO]-3-OXOPROPYL]-2,5-DIOXO-3-PYRROLIDINYL]THIO]HEXYL]AMINO]ETHYL]AMINO]CARBONYL]-2-METHYLALANYL-TERIPARATIDE (2:1)
Product Name: TransCon PTH high-dose pen
INN or Proposed INN: Palopegteriparatide
Other descriptive name: POLY(OXY-1,2-ETHANEDIYL), ALPHA-HYDRO-OMEGA-METHOXY, ETHER WITH N-[[[2-[[6-[[1-[3-[[3-(2,3-DIHYDROXYPROPOXY)PROPYL]AMINO]-3-OXOPROPYL]-2,5-DI
Ascendis Pharma Bone Diseases A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
84Phase 3France;United States;Hungary;Canada;Denmark;Norway;Germany;United Kingdom;Italy
3EUCTR2020-003380-26-DK
(EUCTR)
05/01/202120/10/2020PaTHway TRIAL: A Clinical Trial to Investigate the Safety and Effectiveness of TransCon PTH Administered as an Injection Under the Skin in Adults with Hypoparathyroidism.A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial, with an Open-Label Extension, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Adults with Hypoparathyroidism Hypoparathyroidism in Adults
MedDRA version: 20.0;Level: PT;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: TransCon PTH low-dose pen
INN or Proposed INN: Palopegteriparatide
Other descriptive name: POLY(OXY-1,2-ETHANEDIYL), ALPHA-HYDRO-OMEGA-METHOXY, ETHER WITH N-[[[2-[[6-[[1-[3-[[3-(2,3-DIHYDROXYPROPOXY)PROPYL]AMINO]-3-OXOPROPYL]-2,5-DIOXO-3-PYRROLIDINYL]THIO]HEXYL]AMINO]ETHYL]AMINO]CARBONYL]-2-METHYLALANYL-TERIPARATIDE (2:1)
Product Name: TransCon PTH mid-dose pen
INN or Proposed INN: Palopegteriparatide
Other descriptive name: POLY(OXY-1,2-ETHANEDIYL), ALPHA-HYDRO-OMEGA-METHOXY, ETHER WITH N-[[[2-[[6-[[1-[3-[[3-(2,3-DIHYDROXYPROPOXY)PROPYL]AMINO]-3-OXOPROPYL]-2,5-DIOXO-3-PYRROLIDINYL]THIO]HEXYL]AMINO]ETHYL]AMINO]CARBONYL]-2-METHYLALANYL-TERIPARATIDE (2:1)
Product Name: TransCon PTH high-dose pen
INN or Proposed INN: Palopegteriparatide
Other descriptive name: POLY(OXY-1,2-ETHANEDIYL), ALPHA-HYDRO-OMEGA-METHOXY, ETHER WITH N-[[[2-[[6-[[1-[3-[[3-(2,3-DIHYDROXYPROPOXY)PROPYL]AMINO]-3-OXOPROPYL]-2,5-DI
Ascendis Pharma Bone Diseases A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
84Phase 3United States;France;Hungary;Canada;Denmark;Norway;Germany;United Kingdom;Italy
4EUCTR2020-003380-26-NO
(EUCTR)
16/12/202026/10/2020PaTHway TRIAL: A Clinical Trial to Investigate the Safety and Effectiveness of TransCon PTH Administered as an Injection Under the Skin in Adults with Hypoparathyroidism.A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial, with an Open-Label Extension, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Adults with Hypoparathyroidism Hypoparathyroidism in Adults
MedDRA version: 20.0;Level: PT;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: TransCon PTH low-dose pen
INN or Proposed INN: Palopegteriparatide
Other descriptive name: POLY(OXY-1,2-ETHANEDIYL), ALPHA-HYDRO-OMEGA-METHOXY, ETHER WITH N-[[[2-[[6-[[1-[3-[[3-(2,3-DIHYDROXYPROPOXY)PROPYL]AMINO]-3-OXOPROPYL]-2,5-DIOXO-3-PYRROLIDINYL]THIO]HEXYL]AMINO]ETHYL]AMINO]CARBONYL]-2-METHYLALANYL-TERIPARATIDE (2:1)
Product Name: TransCon PTH mid-dose pen
INN or Proposed INN: Palopegteriparatide
Other descriptive name: POLY(OXY-1,2-ETHANEDIYL), ALPHA-HYDRO-OMEGA-METHOXY, ETHER WITH N-[[[2-[[6-[[1-[3-[[3-(2,3-DIHYDROXYPROPOXY)PROPYL]AMINO]-3-OXOPROPYL]-2,5-DIOXO-3-PYRROLIDINYL]THIO]HEXYL]AMINO]ETHYL]AMINO]CARBONYL]-2-METHYLALANYL-TERIPARATIDE (2:1)
Product Name: TransCon PTH high-dose pen
INN or Proposed INN: Palopegteriparatide
Other descriptive name: POLY(OXY-1,2-ETHANEDIYL), ALPHA-HYDRO-OMEGA-METHOXY, ETHER WITH N-[[[2-[[6-[[1-[3-[[3-(2,3-DIHYDROXYPROPOXY)PROPYL]AMINO]-3-OXOPROPYL]-2,5-DI
Ascendis Pharma Bone Diseases A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
84Phase 3United States;France;Hungary;Canada;Denmark;Germany;Norway;United Kingdom;Italy