nedosiran
Trade name: rivfloza
Nucleic acidapprovedOrphan Drug FDABreakthrough Therapy FDA
Approved
Sep 29, 2023
Clinical trial activity
7 trials · 2 clinical orgs · 2 marketing orgs
Phase 1
2
Phase 2
4
Phase 3
1
Phase 4
0
Earliest trial started Dec 6, 2017 (NCT03392896)
Timeline
2010s
2020s
- Sep 29, 2023
Novo Nordisk — Earliest FDA Approval
- Sep 29, 2023
Novo Nordisk — Marketing Organization
- Sep 29, 2023
Novo — Marketing Organization
- Sep 29, 2023
Novo Nordisk — NDA Organization
Indications
Mechanism of action
- Dihydrodipicolinate synthase-like, mitochondrialANTISENSE INHIBITOR
HOGA1 antisense inhibitor
- L-lactate dehydrogenase A chain mRNARNAI INHIBITOR
L-lactate dehydrogenase A chain mRNA RNAi inhibitor
Approval history
- approvedBreakthroughSep 29, 2023
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
First in class
Sources
- ChEMBLCHEMBL4650244 ↗
- ChEMBLCHEMBL4594338 ↗
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05001269 | Phase 2 | Oct 31, 2021 | Dicerna Pharmaceuticals, Inc. |
| NCT04580420 | Phase 2 | Oct 31, 2020 | Dicerna Pharmaceuticals, Inc. |
| NCT04555486 | Phase 1 | Sep 30, 2020 | Dicerna Pharmaceuticals, Inc. |
| NCT04042402 | Phase 3 | Jul 9, 2019 | Dicerna Pharmaceuticals, Inc. |
| NCT03847909 | Phase 2 | Mar 31, 2019 | Dicerna Pharmaceuticals, Inc. |
| NCT03392896 | Phase 1 | Dec 6, 2017 | Dicerna Pharmaceuticals, Inc. |
| NCT05993416 | N/A | — | Novo Nordisk |
Showing 7 of 7 trials
Page 1 / 1
Organizations
Research & Development (2)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Dicerna Pharmaceuticals, Inc. | For profit | 6 | 6 | 3 | 2017 |
| Novo Nordisk | For profit | 1 | 1 | 1 | — |
2 organizations
Page 1 / 1
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Novo | For profit | MKTG | Sep 29, 2023 |
| Novo Nordisk | For profit | MKTG | Sep 29, 2023 |
| Novo Nordisk | For profit | NDA | Sep 29, 2023 |