olezarsen
Trade name: Tryngolza
Nucleic acidapprovedOrphan Drug FDAFast Track FDABreakthrough Therapy FDA
Approved
Dec 19, 2024
Clinical trial activity
8 trials · 1 clinical orgs · 1 marketing orgs
Phase 1
1
Phase 2
6
Phase 3
5
Phase 4
0
Earliest trial started Nov 30, 2021 (NCT05130450)
Timeline
2020s
- Jan 1, 2021
Ionis Pharmaceuticals, Inc. — Earliest Phase 3 Sponsor(trial)
- Jan 1, 2022
Ionis Pharmaceuticals, Inc. — Earliest Phase 1 Sponsor(trial)
- Jan 1, 2022
Ionis Pharmaceuticals, Inc. — Earliest Phase 2 Sponsor(trial)
- Feb 14, 2024
Orphan Drug Designation
- Dec 19, 2024
Ionis Pharmaceuticals, Inc. — Earliest FDA Approval
- Dec 19, 2024
Ionis Pharmaceuticals, Inc. — NDA Organization
Indications
Approved for
Mechanism of action
- Apolipoprotein C-IIANTISENSE INHIBITOR
APOC2 antisense inhibitor
- Apolipoprotein C-III mRNAANTISENSE INHIBITOR
Apolipoprotein C-III mRNA antisense inhibitor
Antisense inhibitor conjugated to N-acetyl-galactosamine
Approval history
- approvedPriority reviewFast trackBreakthroughDec 19, 2024
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
First in class
Sources
- ChEMBLCHEMBL4650438 ↗
- ChEMBLCHEMBL4650263 ↗
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05681351 | Phase 3 | Dec 13, 2022 | Ionis Pharmaceuticals, Inc. |
| NCT05610280 | Phase 3 | Nov 21, 2022 | Ionis Pharmaceuticals, Inc. |
| NCT05579860 | Phase 1 | Oct 5, 2022 | Ionis Pharmaceuticals, Inc. |
| NCT05552326 | Phase 3 | Aug 31, 2022 | Ionis Pharmaceuticals, Inc. |
| NCT05355402 | Phase 2 | May 9, 2022 | Ionis Pharmaceuticals, Inc. |
| NCT05185843 | Phase 3 | Feb 25, 2022 | Ionis Pharmaceuticals, Inc. |
| NCT05130450 | Phase 3 | Nov 30, 2021 | Ionis Pharmaceuticals, Inc. |
| NCT06360237 | N/A | — | Ionis Pharmaceuticals, Inc. |
Showing 8 of 8 trials
Page 1 / 1
Organizations
Research & Development (1)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Ionis Pharmaceuticals, Inc. | For profit | 8 | 8 | 4 | 2021 |
1 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Ionis Pharmaceuticals, Inc. | For profit | NDA | Dec 19, 2024 |