Somapacitan 15 mg/1.5 mL PDS290 ( DrugBank: Somapacitan )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
195ヌーナン症候群7

195. ヌーナン症候群


臨床試験数 : 25 薬物数 : 23 - (DrugBank : 5) / 標的遺伝子数 : 2 - 標的パスウェイ数 : 9
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-005607-13-NL
(EUCTR)
06/12/202202/06/2022A research study to compare somapacitan once a week with Norditropin® once a day in children who need help to growA study comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® as well as evaluating long-term safety of somapacitan in a basket study design inchildren with short stature either born small for gestational age or with Turner syndrome,Noonan syndrome, or idiopathic short stature. Short stature born small for gestational age Turner syndromeNoonan syndromeIdiopathic short stature
MedDRA version: 20.0;Level: PT;Classification code 10045181;Term: Turner's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10029748;Term: Noonan syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 23.0;Level: LLT;Classification code 10066333;Term: Idiopathic short stature;System Organ Class: 100000004859
MedDRA version: 21.1;Classification code 10041093;Term: Small for gestational age;System Organ Class: 100000004868;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Sogroya 10 mg/1.5 mL solution for injection in pre-filled pen
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Product Name: somapacitan 5 mg/1.5 mL PDS290
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Product Name: Somapacitan 15 mg/1.5 mL PDS290
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Trade Name: Norditropin FlexPro 10 mg/1.5 ml, solution for injection in pre-filled pen
INN or Proposed INN: Somatropin
Other descriptive name: Somatropin
Novo Nordisk A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
395Phase 3United States;Serbia;Saudi Arabia;Greece;Spain;Thailand;Ireland;Israel;Russian Federation;Switzerland;India;Malaysia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Austria;United Kingdom;Mexico;European Union;Canada;Poland;Brazil;Belgium;Croatia;Bulgaria;Germany;Japan
2EUCTR2021-005607-13-DE
(EUCTR)
10/10/202212/05/2022A research study to compare somapacitan once a week with Norditropin® once a day in children who need help to growA study comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® as well as evaluating long-term safety of somapacitan in a basket study design inchildren with short stature either born small for gestational age or with Turner syndrome,Noonan syndrome, or idiopathic short stature. Short stature born small for gestational age Turner syndromeNoonan syndromeIdiopathic short stature
MedDRA version: 20.0;Level: PT;Classification code 10045181;Term: Turner's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10029748;Term: Noonan syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 23.0;Level: LLT;Classification code 10066333;Term: Idiopathic short stature;System Organ Class: 100000004859
MedDRA version: 21.1;Classification code 10041093;Term: Small for gestational age;System Organ Class: 100000004868;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Sogroya 10 mg/1.5 mL solution for injection in pre-filled pen
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Product Name: somapacitan 5 mg/1.5 mL PDS290
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Product Name: Somapacitan 15 mg/1.5 mL PDS290
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Trade Name: Norditropin FlexPro 10 mg/1.5 ml, solution for injection in pre-filled pen
INN or Proposed INN: Somatropin
Other descriptive name: Somatropin
Novo Nordisk A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
395Phase 3United States;Serbia;Saudi Arabia;Greece;Spain;Thailand;Ireland;Israel;Russian Federation;Switzerland;India;Malaysia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Austria;United Kingdom;Mexico;European Union;Canada;Poland;Brazil;Belgium;Croatia;Bulgaria;Germany;Japan
3EUCTR2021-005607-13-SI
(EUCTR)
20/06/202229/04/2022A research study to compare somapacitan once a week with Norditropin® once a day in children who need help to growA study comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® as well as evaluating long-term safety of somapacitan in a basket study design inchildren with short stature either born small for gestational age or with Turner syndrome,Noonan syndrome, or idiopathic short stature. Short stature born small for gestational age Turner syndromeNoonan syndromeIdiopathic short stature
MedDRA version: 20.0;Level: PT;Classification code 10045181;Term: Turner's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10029748;Term: Noonan syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 23.0;Level: LLT;Classification code 10066333;Term: Idiopathic short stature;System Organ Class: 100000004859
MedDRA version: 21.1;Classification code 10041093;Term: Small for gestational age;System Organ Class: 100000004868;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Sogroya 10 mg/1.5 mL solution for injection in pre-filled pen
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Product Name: somapacitan 5 mg/1.5 mL PDS290
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Product Name: Somapacitan 15 mg/1.5 mL PDS290
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Trade Name: Norditropin FlexPro 10 mg/1.5 ml, solution for injection in pre-filled pen
INN or Proposed INN: Somatropin
Other descriptive name: Somatropin
Novo Nordisk A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
395Phase 3Serbia;United States;Saudi Arabia;Greece;Spain;Thailand;Ireland;Russian Federation;Israel;Switzerland;India;Malaysia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Austria;United Kingdom;Mexico;European Union;Canada;Poland;Brazil;Belgium;Croatia;Bulgaria;Germany;Japan
4EUCTR2021-005607-13-GR
(EUCTR)
25/05/2022A research study to compare somapacitan once a week with Norditropin® once a day in children who need help to growA study comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® as well as evaluating long-term safety of somapacitan in a basket study design inchildren with short stature either born small for gestational age or with Turner syndrome,Noonan syndrome, or idiopathic short stature. Short stature born small for gestational age Turner syndromeNoonan syndromeIdiopathic short stature
MedDRA version: 20.0;Level: PT;Classification code 10045181;Term: Turner's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10029748;Term: Noonan syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 23.0;Level: LLT;Classification code 10066333;Term: Idiopathic short stature;System Organ Class: 100000004859
MedDRA version: 21.1;Classification code 10041093;Term: Small for gestational age;System Organ Class: 100000004868;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Sogroya 10 mg/1.5 mL solution for injection in pre-filled pen
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Product Name: somapacitan 5 mg/1.5 mL PDS290
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Product Name: Somapacitan 15 mg/1.5 mL PDS290
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Trade Name: Norditropin FlexPro 10 mg/1.5 ml, solution for injection in pre-filled pen
INN or Proposed INN: Somatropin
Other descriptive name: Somatropin
Novo Nordisk A/SNULLNAFemale: yes
Male: yes
395Phase 3United States;Serbia;Saudi Arabia;Greece;Thailand;Ireland;Israel;Russian Federation;Switzerland;India;Malaysia;South Africa;Netherlands;China;Korea, Republic of;Finland;Austria;United Kingdom;Mexico;European Union;Canada;Brazil;Belgium;Poland;Japan
5EUCTR2021-005607-13-PL
(EUCTR)
03/08/2022A research study to compare somapacitan once a week with Norditropin® once a day in children who need help to growA study comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® as well as evaluating long-term safety of somapacitan in a basket study design inchildren with short stature either born small for gestational age or with Turner syndrome,Noonan syndrome, or idiopathic short stature. Short stature born small for gestational age Turner syndromeNoonan syndromeIdiopathic short stature
MedDRA version: 20.0;Level: PT;Classification code 10045181;Term: Turner's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10029748;Term: Noonan syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 23.0;Level: LLT;Classification code 10066333;Term: Idiopathic short stature;System Organ Class: 100000004859
MedDRA version: 21.1;Classification code 10041093;Term: Small for gestational age;System Organ Class: 100000004868;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Sogroya 10 mg/1.5 mL solution for injection in pre-filled pen
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Product Name: somapacitan 5 mg/1.5 mL PDS290
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Product Name: Somapacitan 15 mg/1.5 mL PDS290
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Trade Name: Norditropin FlexPro 10 mg/1.5 ml, solution for injection in pre-filled pen
INN or Proposed INN: Somatropin
Other descriptive name: Somatropin
Novo Nordisk A/SNULLNAFemale: yes
Male: yes
395Phase 3Russian Federation;United States;Malaysia;Thailand;Saudi Arabia;Greece;Netherlands;Austria;China;Ireland;Poland;Brazil;Korea, Republic of;Slovenia;Serbia;Bulgaria;Croatia;Japan;United Kingdom;Switzerland;India;Spain;Canada;Belgium;European Union;Finland;Mexico;South Africa;Israel;Germany
6EUCTR2021-005607-13-IE
(EUCTR)
10/05/2022A research study to compare somapacitan once a week with Norditropin® once a day in children who need help to growA study comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® as well as evaluating long-term safety of somapacitan in a basket study design inchildren with short stature either born small for gestational age or with Turner syndrome,Noonan syndrome, or idiopathic short stature. Short stature born small for gestational age Turner syndromeNoonan syndromeIdiopathic short stature
MedDRA version: 20.0;Level: PT;Classification code 10045181;Term: Turner's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10029748;Term: Noonan syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 23.0;Level: LLT;Classification code 10066333;Term: Idiopathic short stature;System Organ Class: 100000004859
MedDRA version: 21.1;Classification code 10041093;Term: Small for gestational age;System Organ Class: 100000004868;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Sogroya 10 mg/1.5 mL solution for injection in pre-filled pen
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Product Name: somapacitan 5 mg/1.5 mL PDS290
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Product Name: Somapacitan 15 mg/1.5 mL PDS290
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Trade Name: Norditropin FlexPro 10 mg/1.5 ml, solution for injection in pre-filled pen
INN or Proposed INN: Somatropin
Other descriptive name: Somatropin
Novo Nordisk A/SNULLNAFemale: yes
Male: yes
395Phase 3United States;Serbia;Saudi Arabia;Greece;Thailand;Ireland;Israel;Russian Federation;Switzerland;India;Malaysia;South Africa;Netherlands;China;Korea, Republic of;Finland;Austria;United Kingdom;Mexico;European Union;Canada;Brazil;Belgium;Poland;Japan
7EUCTR2021-005607-13-BE
(EUCTR)
07/06/2022A research study to compare somapacitan once a week with Norditropin® once a day in children who need help to growA study comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® as well as evaluating long-term safety of somapacitan in a basket study design inchildren with short stature either born small for gestational age or with Turner syndrome,Noonan syndrome, or idiopathic short stature. Short stature born small for gestational age Turner syndromeNoonan syndromeIdiopathic short stature
MedDRA version: 20.0;Level: PT;Classification code 10045181;Term: Turner's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10029748;Term: Noonan syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 23.0;Level: LLT;Classification code 10066333;Term: Idiopathic short stature;System Organ Class: 100000004859
MedDRA version: 21.1;Classification code 10041093;Term: Small for gestational age;System Organ Class: 100000004868;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Sogroya 10 mg/1.5 mL solution for injection in pre-filled pen
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Trade Name: Sogroya 5 mg/1.5 mL solution for injection in pre-filled pen
Product Name: somapacitan 5 mg/1.5 mL PDS290
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Product Name: Somapacitan 15 mg/1.5 mL PDS290
INN or Proposed INN: Somapacitan
Other descriptive name: Somapacitan
Trade Name: Norditropin FlexPro 10 mg/1.5 ml, solution for injection in pre-filled pen
INN or Proposed INN: Somatropin
Other descriptive name: Somatropin
Novo Nordisk A/SNULLNAFemale: yes
Male: yes
395Phase 3United States;Serbia;Saudi Arabia;Greece;Thailand;Ireland;Israel;Russian Federation;Switzerland;India;Malaysia;South Africa;Netherlands;China;Korea, Republic of;Finland;Austria;United Kingdom;Mexico;European Union;Canada;Brazil;Belgium;Poland;Japan