givinostat
Trade name: Duvyzat
Small moleculeapprovedOrphan Drug FDAFast Track FDA
Approved
Mar 21, 2024
Givinostat, sold under the brand name Duvyzat is a medication used for the treatment of Duchenne muscular dystrophy. It is a histone deacetylase inhibitor with potential anti-inflammatory, anti-angiogenic, and antineoplastic activities. It is a histone deacetylase (HDAC) inhibitor that works by targeting pathogenic processes to reduce inflammation and loss of muscle. — Wikipedia
Clinical trial activity
25 trials · 14 clinical orgs · 1 marketing orgs
Phase 1
10
Phase 2
18
Phase 3
4
Phase 4
0
Earliest trial started Aug 1, 2006 (NCT00570661)
Timeline
2000s
- Jan 1, 2006
Italfarmaco — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2007
Italfarmaco — Earliest Phase 1 Sponsor(trial)
2010s
- Apr 12, 2013
Orphan Drug Designation
- Jan 1, 2017
Italfarmaco — Earliest Phase 3 Sponsor(trial)
2020s
- Mar 21, 2024
Italfarmaco — Earliest FDA Approval
- Mar 21, 2024
Italfarmaco — NDA Organization
Indications
Approved for
Studied for
- Abdominoplasty · Phase 2
- Arthritis, Juvenile · Phase 2
- Crohn Disease · Phase 1/Phase 2
- Drug Interactions · Phase 1
- Hodgkin Disease · Phase 1/Phase 2
- Immunoglobulin D · Phase 2
- Inflammation · Phase 2
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 2
- Liver Diseases · Phase 1
- Multiple Myeloma · Phase 2
- Muscular Dystrophy, Duchenne · Phase 3
- Myeloproliferative Disorders · Phase 2
- Polycythemia Vera · Phase 3
- Receptors, Tumor Necrosis Factor · Phase 2
- Schnitzler Syndrome · Phase 2
- Volunteers · Phase 1
Mechanism of action
- Histone deacetylase 2INHIBITOR
HDAC2 inhibitor
- Histone deacetylaseINHIBITOR
Histone deacetylase inhibitor
- Histone deacetylase 1 (HDAC1) ↗
- Histone deacetylase 3 (HDAC3) ↗
- Histone deacetylase 6 (HDAC6) ↗
- Histone deacetylase 2 (HDAC2) ↗
- Histone deacetylase 5 (HDAC5) ↗
- Histone deacetylase 7 (HDAC7) ↗
- Histone deacetylase 8 (HDAC8) ↗
- Histone deacetylase 11 (HDAC11) ↗
- Histone deacetylase 4 (HDAC4) ↗
- Histone deacetylase 9 (HDAC9) ↗
- Histone deacetylase 10 (HDAC10) ↗
- Histone deacetylase 8
- Histone deacetylase 10
- Histone deacetylase 2
- Histone deacetylase 3
- Histone deacetylase 4
- Histone deacetylase 6
- Histone deacetylase 9
- Histone deacetylase 11
- Histone deacetylase 5
- Histone deacetylase 7
- Histone deacetylase 1
- Histone deacetylase (HDAC1 and HDAC2)
- Histone deacetylase 1/3/5/8
- Histone deacetylase 1/2/3/6
- Histone deacetylase 1/2/3
- Histone deacetylase 1/8
- Histone deacetylase 1/6
- Class 1 histone deacetylase
- Histone deacetylase 6/3
Approval history
- approvedPriority reviewFast trackMar 21, 2024
Chemistry & pharmacology
Loading structure…
SMILES
CCN(CC)Cc1ccc2cc(COC(=O)Nc3ccc(C(=O)NO)cc3)ccc2c1- Mol. weight
- 421.5 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
First in class
Sources
- WikipediaGivinostat ↗
- ChEMBLCHEMBL6068400 ↗
- ChEMBLCHEMBL1213492 ↗
Also known as
- givinostat
- givinostat
- givinostat
- givinostat hydrochloride
- givinostat (hydrochloride)
- itf2357
- itf2357
- itf2357
- itf 2357
- itf2357 (givinostat)
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06736223 | Phase 1 | Apr 30, 2025 | Biotrial, Italfarmaco |
| NCT06769633 | Phase 2 | Jan 2, 2025 | Fortrea, Italfarmaco |
| NCT05933057 | Phase 3 | Dec 31, 2023 | Italfarmaco |
| NCT06093672 | Phase 3 | Dec 31, 2023 | Italfarmaco |
| NCT05492318 | Phase 1 | Mar 21, 2022 | Italfarmaco |
| NCT05860114 | Phase 1 | Mar 21, 2022 | Blueclinical, Ltd., Italfarmaco |
| NCT05845567 | Phase 1 | Mar 21, 2022 | Blueclinical, Ltd., Italfarmaco |
| NCT04821063 | Phase 1 | Apr 13, 2021 | Italfarmaco |
| NCT03238235 | Phase 2 | Dec 12, 2017 | A.O. Ospedale Maggiore di Lodi, Italfarmaco |
| NCT03373968 | Phase 2/Phase 3 (Phase 3) | Oct 24, 2017 | Cromsource, Italfarmaco |
| NCT02851797 | Phase 3 | Apr 1, 2017 | inVentiv, Italfarmaco |
| NCT01901432 | Phase 1/Phase 2 (Phase 2) | Oct 1, 2013 | Italfarmaco |
| NCT01761292 | Phase 1/Phase 2 (Phase 2) | May 1, 2013 | Italfarmaco |
| NCT01761968 | Phase 2 | Mar 1, 2013 | Italfarmaco, University of Brescia |
| NCT01557452 | N/A | Dec 1, 2011 | Italfarmaco, Parexel |
| NCT01261624 | Phase 2 | Oct 1, 2010 | Italfarmaco |
| NCT00928707 | Phase 2 | Jun 1, 2009 | Italfarmaco, University of Milan |
| NCT00792506 | Phase 2 | Oct 1, 2008 | Italfarmaco, University of Cagliari |
| NCT00792467 | Phase 1/Phase 2 (Phase 2) | Feb 1, 2008 | Italfarmaco, University of Milan |
| NCT00792831 | Phase 2 | Feb 1, 2008 | Italfarmaco, University of Perugia |
Showing 20 of 25 trials
Page 1 / 2
Organizations
Research & Development (14)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Italfarmaco | For profit | 24 | 24 | 4 | 2006 |
| University of Milan | Academic/Hospital | 3 | 0 | 1 | 2007 |
| Blueclinical, Ltd. | For profit | 2 | 0 | 1 | 2022 |
| University of Brescia | Academic/Hospital | 2 | 0 | 1 | 2007 |
| A.O. Ospedale Maggiore di Lodi | Academic/Hospital | 1 | 0 | 1 | 2017 |
| Biotrial | For profit | 1 | 0 | 1 | 2025 |
| Cromsource | For profit | 1 | 0 | 1 | 2017 |
| Fortrea | For profit | 1 | 0 | 1 | 2025 |
| inVentiv | For profit | 1 | 0 | 1 | 2017 |
| Katholieke Universiteit Leuven | Academic/Hospital | 1 | 0 | 1 | 2007 |
| Parexel | For profit | 1 | 0 | 1 | 2011 |
| Radboud University | Academic/Hospital | 1 | 1 | 1 | 2006 |
| University of Cagliari | Academic/Hospital | 1 | 0 | 1 | 2008 |
| University of Perugia | Academic/Hospital | 1 | 0 | 1 | 2008 |
14 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Italfarmaco | For profit | NDA | Mar 21, 2024 |