palopegteriparatide
Trade name: Yorvipath
PeptideapprovedOrphan Drug FDA
Approved
Aug 9, 2024
Clinical trial activity
2 trials · 2 clinical orgs · 1 marketing orgs
Phase 1
0
Phase 2
1
Phase 3
1
Phase 4
0
Earliest trial started Nov 30, 2025 (NCT07081997)
Timeline
2010s
- Jun 4, 2018
Orphan Drug Designation
2020s
- Aug 9, 2024
Ascendis Pharma, Inc. — Earliest FDA Approval
- Aug 9, 2024
Ascendis Pharma, Inc. — NDA Organization
- Jan 1, 2025
Ascendis Pharma, Inc. — Earliest Phase 3 Sponsor(trial)
Indications
Approved for
Mechanism of action
- Parathyroid hormone receptorAGONIST
Parathyroid hormone receptor agonist
CHRNA7 agonist
Approval history
- approvedPriority reviewAug 9, 2024
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Prodrug
Sources
- ChEMBLCHEMBL5095475 ↗
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07081997 | Phase 3 | Nov 30, 2025 | Ascendis Pharma, Inc. |
| NCT05654701 | N/A | — | Ascendis Pharma, Inc., Clinigene International Ltd |
Showing 2 of 2 trials
Page 1 / 1
Organizations
Research & Development (2)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Ascendis Pharma, Inc. | For profit | 2 | 2 | 2 | 2025 |
| Clinigene International Ltd | For profit | 1 | 0 | 1 | — |
2 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Ascendis Pharma, Inc. | For profit | NDA | Aug 9, 2024 |