lonapegsomatropin
Trade name: Skytrofa
Recombinant proteinapprovedOrphan Drug FDA
Approved
Aug 25, 2021
Clinical trial activity
9 trials · 4 clinical orgs · 1 marketing orgs
Phase 1
1
Phase 2
7
Phase 3
3
Phase 4
0
Earliest trial started Nov 1, 2009 (NCT01010425)
Timeline
2000s
- Jan 1, 2009
Ascendis Pharma, Inc. — Earliest Phase 1 Sponsor(trial)
2010s
- Jan 1, 2010
Ascendis Pharma, Inc. — Earliest Phase 2 Sponsor(trial)
2020s
- Jan 1, 2020
Ascendis Pharma, Inc. — Earliest Phase 3 Sponsor(trial)
- Apr 13, 2020
Orphan Drug Designation
- Aug 25, 2021
Ascendis Pharma, Inc. — Earliest FDA Approval
- Aug 25, 2021
Ascendis Pharma, Inc. — Marketing Organization
- Aug 25, 2021
Ascendis Pharma, Inc. — NDA Secondary Org
- Aug 25, 2021
Ascendis Pharma, Inc. — NDA Organization
Indications
Approved for
Mechanism of action
- Growth hormone receptorAGONIST
GHR agonist
Approval history
- approvedAug 25, 2021
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Prodrug
Sources
- ChEMBLCHEMBL4298185 ↗
Also known as
- acp-001
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07221851 | Phase 3 | Nov 30, 2025 | Ascendis Pharma, Inc. |
| NCT06433557 | Phase 2 | Jul 26, 2024 | Ascendis Pharma, Inc. |
| NCT05690386 | Phase 2 | Feb 15, 2023 | Ascendis Pharma, Inc. |
| NCT05171855 | Phase 3 | Dec 16, 2021 | Ascendis Pharma, Inc. |
| NCT04615273 | Phase 3 | Nov 30, 2020 | Ascendis Pharma, Inc. |
| NCT01947907 | Phase 2 | Jul 1, 2013 | Ascendis Pharma, Inc., University of Lyon |
| NCT01247675 | Phase 2 | Nov 1, 2010 | Ascendis Pharma, Inc. |
| NCT01614223 | N/A | Sep 1, 2010 | Arthrex, Inc., University of Western Ontario |
| NCT01010425 | Phase 1 | Nov 1, 2009 | Ascendis Pharma, Inc. |
Showing 9 of 9 trials
Page 1 / 1
Organizations
Research & Development (4)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Ascendis Pharma, Inc. | For profit | 8 | 8 | 3 | 2009 |
| Arthrex, Inc. | For profit | 1 | 0 | 1 | 2010 |
| University of Lyon | Academic/Hospital | 1 | 0 | 1 | 2013 |
| University of Western Ontario | Academic/Hospital | 1 | 1 | 1 | 2010 |
4 organizations
Page 1 / 1
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Ascendis Pharma, Inc. | For profit | MKTG | Aug 25, 2021 |
| Ascendis Pharma, Inc. | For profit | NDA2 | Aug 25, 2021 |
| Ascendis Pharma, Inc. | For profit | NDA | Aug 25, 2021 |