NNC0195-0092: consists of mutated human growth hormone linked to a fatty acid that promotes binding to serum albumin [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]
| ID Source | ID |
|---|---|
| PubMed CID | 129894493 |
| MeSH ID | M000601648 |
| Synonym |
|---|
| nn8640 |
| nnc0195-0092 |
| somapacitan |
| somapacitan [usan:inn] |
| somapacitan [usan:inn:who-dd] |
| somapacitan [who-dd] |
| somapacitan [inn] |
| 1338578-34-9 |
| unii-8foj430u94 |
| 8foj430u94 , |
| Q27270325 |
| EX-A4353 |
| Excerpt | Reference |
|---|---|
| " Pharmacokinetic models were developed for somapacitan and metabolite P1 and used for steady-state assessment in the rat." | ( Structure identification of circulating metabolites from somapacitan, a long-acting growth hormone derivative, and pharmacokinetics after single and multiple subcutaneous dosing in rats. Bjelke, M; Helleberg, H; Lindecrona, RH; Thygesen, P, 2022) |
| Excerpt | Reference |
|---|---|
| "Linear models provided a simple and reliable tool to aid optimal monitoring of IGF-I by predicting mean and peak IGF-I levels based on an IGF-I sample following dosing of somapacitan." | ( Optimal Monitoring of Weekly IGF-I Levels During Growth Hormone Therapy With Once-Weekly Somapacitan. Agersø, H; Højby Rasmussen, M; Juul Kildemoes, R; Overgaard, RV, 2021) |
| "Somapacitan is a growth hormone derivative approved for once-weekly treatment of growth hormone deficiency in adults and currently in clinical development for once-weekly dosing in children." | ( Structure identification of circulating metabolites from somapacitan, a long-acting growth hormone derivative, and pharmacokinetics after single and multiple subcutaneous dosing in rats. Bjelke, M; Helleberg, H; Lindecrona, RH; Thygesen, P, 2022) |
| " The aim of this study was to provide clinical guidance on dosing and titration of the novel long-acting GH derivative somapacitan based on analyses of somapacitan dose-insulin-like growth factor I (IGF-I) responses in AGHD patients." | ( Dose-exposure-IGF-I response of once-weekly somapacitan in adults with GH deficiency. Biller, BMK; Hollensen, C; Johannsson, G; Kildemoes, RJ; Rasmussen, MH; Takahashi, Y, 2022) |
| "Analyses of dosing information, 4364 somapacitan concentration samples and 4880 IGF-I samples from 330 AGHD patients treated with somapacitan in three phase 3 trials." | ( Dose-exposure-IGF-I response of once-weekly somapacitan in adults with GH deficiency. Biller, BMK; Hollensen, C; Johannsson, G; Kildemoes, RJ; Rasmussen, MH; Takahashi, Y, 2022) |
| " Simulations of IGF-I SDS profiles confirmed the appropriate time for IGF-I sampling to be 3-4 days after somapacitan dosing and supported somapacitan administration with up to 3 days delay in case of missed dosing." | ( Dose-exposure-IGF-I response of once-weekly somapacitan in adults with GH deficiency. Biller, BMK; Hollensen, C; Johannsson, G; Kildemoes, RJ; Rasmussen, MH; Takahashi, Y, 2022) |
| "This study extends the knowledge of the somapacitan dose-IGF-I response and provides information on clinical dosing of once-weekly somapacitan in patients with AGHD." | ( Dose-exposure-IGF-I response of once-weekly somapacitan in adults with GH deficiency. Biller, BMK; Hollensen, C; Johannsson, G; Kildemoes, RJ; Rasmussen, MH; Takahashi, Y, 2022) |
| Timeframe | Studies, This Drug (%) | All Drugs % |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 0 (0.00) | 29.6817 |
| 2010's | 2 (10.53) | 24.3611 |
| 2020's | 17 (89.47) | 2.80 |
| [information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023] | ||
| Publication Type | This drug (%) | All Drugs (%) |
|---|---|---|
| Trials | 11 (57.89%) | 5.53% |
| Reviews | 4 (21.05%) | 6.00% |
| Case Studies | 0 (0.00%) | 4.05% |
| Observational | 0 (0.00%) | 0.25% |
| Other | 4 (21.05%) | 84.16% |
| [information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023] | ||