long-acting insulin analogue
Insulin degludec companies
Answer
Public registers name 3 licence holders, 2 bulk ingredient labelers, 3 US labelers, 42 trial sponsors and 1 recalling firm for Insulin degludec.
Each row is what a register states. A company named here is not endorsed or accused by this site.
MARKETING AUTHORISATION HOLDER
3 companies
Holds the licence to sell the medicine in a country (EMA, MHRA, Health Canada).
| Novo Nordisk A/S | Ryzodeg (EMEA/H/C/002499), Authorised Regulator EMA Tresiba (EMEA/H/C/002498), Authorised Regulator EMA |
|---|---|
| NOVO NORDISK AS | TRESIBA 100 UNITS/ML SOLUTION FOR INJECTION IN CARTRIDGE, PLGB 04668/0411, Authorised Regulator MHRA TRESIBA 200 UNITS/ML SOLUTION FOR INJECTION IN PRE FILLED PEN, PLGB 04668/0412, Authorised Regulator MHRA XULTOPHY 100 UNITS/ML + 3.6 MG/ML SOLUTION FOR INJECTION, PLGB 04668/0414, Authorised Regulator MHRA |
| NOVO NORDISK CANADA INC | TRESIBA (DIN 02467860), Marketed Regulator Health Canada TRESIBA (DIN 02467879), Marketed Regulator Health Canada TRESIBA (DIN 02467887), Marketed Regulator Health Canada and 1 more entries |
BULK INGREDIENT LABELER
2 companies
Lists the bulk active ingredient with FDA (NDC directory).
| Amphastar Nanjing Pharmaceuticals, Inc. | Insulin Degludec, BULK INGREDIENT Regulator openFDA |
|---|---|
| Hefei Xinzhu Biological Technology Co., Ltd. | Insulin Degludec, BULK INGREDIENT Regulator openFDA |
US LABELER
3 companies
Lists a finished product with FDA (NDC directory); can be a maker, repackager or distributor.
| A-S Medication Solutions | Insulin Degludec, BLA Regulator openFDA Tresiba, BLA Regulator openFDA TRESIBA, BLA Regulator openFDA |
|---|---|
| Novo Nordisk | Tresiba, BLA Regulator openFDA Xultophy 100/3.6, BLA Regulator openFDA |
| Novo Nordisk Pharma, Inc. | Insulin Degludec, BLA Regulator openFDA |
TRIAL SPONSOR
42 companies
Sponsors registered clinical trials of the peptide.
| Novo Nordisk A/S | 144 registered trials Trial register ClinicalTrials.gov 2 registered trials Trial register EU CTIS |
|---|---|
| Eli Lilly & Company | 17 registered trials Trial register ClinicalTrials.gov |
| Gan and Lee Pharmaceuticals, USA | 5 registered trials Trial register ClinicalTrials.gov |
| Sanofi | 5 registered trials Trial register ClinicalTrials.gov |
| Gan & Lee Pharmaceuticals. | 3 registered trials Trial register ClinicalTrials.gov |
| Jiangsu HengRui Medicine Co., Ltd. | 3 registered trials Trial register ClinicalTrials.gov |
| Diasome Pharmaceuticals | 2 registered trials Trial register ClinicalTrials.gov |
| Emory University | 2 registered trials Trial register ClinicalTrials.gov |
| Gan & Lee Pharmaceuticals USA Corp. | 2 registered trials Trial register EU CTIS |
| Insel Gruppe AG, University Hospital Bern | 2 registered trials Trial register ClinicalTrials.gov |
| Mannkind Corporation | 2 registered trials Trial register ClinicalTrials.gov |
| Sunshine Lake Pharma Co., Ltd. | 2 registered trials Trial register ClinicalTrials.gov |
| Tonghua Dongbao Pharmaceutical Co., Ltd | 2 registered trials Trial register ClinicalTrials.gov |
| Ain Shams University | 1 registered trial Trial register ClinicalTrials.gov |
| Beijing Hospital | 1 registered trial Trial register ClinicalTrials.gov |
| Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | 1 registered trial Trial register ClinicalTrials.gov |
| Elaine Chow | 1 registered trial Trial register ClinicalTrials.gov |
| Glooko | 1 registered trial Trial register ClinicalTrials.gov |
| Hennepin Healthcare Research Institute | 1 registered trial Trial register ClinicalTrials.gov |
| Hospital Universitario San Ignacio | 1 registered trial Trial register ClinicalTrials.gov |
| Huashan Hospital | 1 registered trial Trial register ClinicalTrials.gov |
| LMC Diabetes & Endocrinology Ltd. | 1 registered trial Trial register ClinicalTrials.gov |
| Merete Bechmann Christensen | 1 registered trial Trial register ClinicalTrials.gov |
| Nordsjaellands Hospital | 1 registered trial Trial register ClinicalTrials.gov |
| Peking University People's Hospital | 1 registered trial Trial register ClinicalTrials.gov |
| Population Health Research Institute | 1 registered trial Trial register ClinicalTrials.gov |
| prof dr Pieter Gillard | 1 registered trial Trial register ClinicalTrials.gov |
| Sansum Diabetes Research Institute | 1 registered trial Trial register ClinicalTrials.gov |
| Second Affiliated Hospital, Zhejiang University, School of Medicine | 1 registered trial Trial register ClinicalTrials.gov |
| Stefano Rizza | 1 registered trial Trial register ClinicalTrials.gov |
| The Cleveland Clinic | 1 registered trial Trial register ClinicalTrials.gov |
| The United Bio-Technology (Hengqin) Co., Ltd. | 1 registered trial Trial register ClinicalTrials.gov |
| Universita Cattolica Del Sacro Cuore | 1 registered trial Trial register EU CTIS |
| University of Colorado, Denver | 1 registered trial Trial register ClinicalTrials.gov |
| University of Guadalajara | 1 registered trial Trial register ClinicalTrials.gov |
| University of Padova | 1 registered trial Trial register ClinicalTrials.gov |
| University of Palermo | 1 registered trial Trial register ClinicalTrials.gov |
| University of Split, School of Medicine | 1 registered trial Trial register ClinicalTrials.gov |
| University of Washington | 1 registered trial Trial register ClinicalTrials.gov |
| Weill Cornell Medical College in Qatar | 1 registered trial Trial register ClinicalTrials.gov |
Showing 40 of 42.
RECALLING FIRM
1 company
Recalled a product naming the peptide (FDA enforcement report).
| Novo Nordisk Inc | Class I recall, Terminated, 2021-04-21 Regulator openFDA |
|---|
Every company across all peptides: companies. Names are matched only when identical apart from case and punctuation, so one group can appear under two spellings.
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