somapacitan
Trade name: Sogroya
Small moleculeapprovedOrphan Drug FDA
Approved
Aug 28, 2020
Clinical trial activity
16 trials · 1 clinical orgs · 1 marketing orgs
Phase 1
7
Phase 2
9
Phase 3
7
Phase 4
0
Earliest trial started Jan 16, 2012 (NCT01514500)
Timeline
1980s
- Jul 10, 1987
Orphan Drug Designation
2010s
- Jan 1, 2012
Novo Nordisk — Earliest Phase 1 Sponsor(trial)
- Jan 1, 2014
Novo Nordisk — Earliest Phase 3 Sponsor(trial)
- Jan 1, 2016
Novo Nordisk — Earliest Phase 2 Sponsor(trial)
2020s
- Aug 28, 2020
Novo Nordisk — Earliest FDA Approval
- Aug 28, 2020
Novo Nordisk — Marketing Organization
- Aug 28, 2020
Novo Nordisk — NDA Secondary Org
- Aug 28, 2020
Novo Nordisk — NDA Organization
Indications
Approved for
Mechanism of action
- Growth hormone receptorAGONIST
GHR agonist
Approval history
- approvedAug 28, 2020
Chemistry & pharmacology
Loading structure…
SMILES
C=C(CCCCCCCCCCCCCCCc1nnn[nH]1)NS(=O)(=O)CCCC(=O)NCCOCCOCC(=O)N[C@@H](CCC(=O)N[C@@H](CCC(=O)NCCOCCOCC(=O)N[C@@H](CCCCNC(=O)CSC[C@H](N)C(=O)O)C(N)=O)C(=O)O)C(=O)O- Mol. weight
- 1308.59 g/mol
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Sources
- ChEMBLCHEMBL3707290 ↗
Also known as
- nn-8640
- nn-8640
- nnc0195-0092
- nnc0195-0092
- nnc0195-0092
- somapacitan
- somapacitan
- somapacitan
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05723835 | Phase 3 | Feb 1, 2023 | Novo Nordisk |
| NCT05330325 | Phase 3 | Aug 10, 2022 | Novo Nordisk |
| NCT04970654 | Phase 3 | Jul 22, 2021 | Novo Nordisk |
| NCT03878446 | Phase 2 | May 20, 2019 | Novo Nordisk |
| NCT03811535 | Phase 3 | May 20, 2019 | Novo Nordisk |
| NCT03905850 | Phase 1 | Mar 29, 2019 | Novo Nordisk |
| NCT03212131 | Phase 1 | Aug 16, 2017 | Novo Nordisk |
| NCT03186495 | Phase 1 | Jun 20, 2017 | Novo Nordisk |
| NCT03075644 | Phase 3 | Mar 3, 2017 | Novo Nordisk |
| NCT02962440 | Phase 1 | Nov 1, 2016 | Novo Nordisk |
| NCT02616562 | Phase 2 | Mar 23, 2016 | Novo Nordisk |
| NCT02382939 | Phase 3 | Feb 1, 2015 | Novo Nordisk |
| NCT02229851 | Phase 3 | Oct 30, 2014 | Novo Nordisk |
| NCT01973244 | Phase 1 | Dec 1, 2013 | Novo Nordisk |
| NCT01706783 | Phase 1 | Oct 12, 2012 | Novo Nordisk |
| NCT01514500 | Phase 1 | Jan 16, 2012 | Novo Nordisk |
Showing 16 of 16 trials
Page 1 / 1
Organizations
Research & Development (1)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Novo Nordisk | For profit | 16 | 16 | 3 | 2012 |
1 organizations
Page 1 / 1
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Novo Nordisk | For profit | MKTG | Aug 28, 2020 |
| Novo Nordisk | For profit | NDA2 | Aug 28, 2020 |
| Novo Nordisk | For profit | NDA | Aug 28, 2020 |