lentiglobin bb305
Trade name: Zynteglo
Gene therapyapprovedOrphan Drug FDABreakthrough Therapy FDA
Approved
Aug 17, 2022
Clinical trial activity
6 trials · 1 clinical orgs · 1 marketing orgs
Phase 1
3
Phase 2
5
Phase 3
3
Phase 4
0
Earliest trial started Jul 1, 2013 (NCT02151526)
Timeline
2010s
- Jan 1, 2013
bluebird bio — Earliest Phase 1 Sponsor(trial)
- Mar 18, 2013
Orphan Drug Designation
- Jan 1, 2016
bluebird bio — Earliest Phase 3 Sponsor(trial)
2020s
- Aug 17, 2022
bluebird bio — Earliest FDA Approval
- Aug 17, 2022
bluebird bio — NDA Secondary Org
- Aug 17, 2022
bluebird bio — NDA Organization
Indications
Approved for
Mechanism of action
- Hemoglobin beta chainAGONIST
HBB agonist
- Hemoglobin beta chainEXOGENOUS GENE
Hemoglobin beta chain exogenous gene
Provides a source of beta-globin.
Approval history
- approvedBreakthroughAug 17, 2022
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL4594311 ↗
Also known as
- lentiglobin bb305
- lentiglobin bb305 drug product
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT04293185 | Phase 3 | Feb 14, 2020 | bluebird bio |
| NCT03207009 | Phase 3 | Jun 8, 2017 | bluebird bio |
| NCT02906202 | Phase 3 | Jul 1, 2016 | bluebird bio |
| NCT02140554 | Phase 1 | Aug 1, 2014 | bluebird bio |
| NCT01745120 | Phase 1/Phase 2 (Phase 2) | Aug 1, 2013 | bluebird bio |
| NCT02151526 | Phase 1/Phase 2 (Phase 2) | Jul 1, 2013 | bluebird bio |
Showing 6 of 6 trials
Page 1 / 1
Organizations
Research & Development (1)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| bluebird bio | For profit | 6 | 6 | 3 | 2013 |
1 organizations
Page 1 / 1
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| bluebird bio | For profit | NDA2 | Aug 17, 2022 |
| bluebird bio | For profit | NDA | Aug 17, 2022 |