Drugs / zatolmilast
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials | ||||||
| Phase 1 | NCT07018492 | Aug → Nov 2025 | — | Shionogi | Completed | No outcome recorded |
| Phase 1 | NCT07012005 | Aug → Dec 2025 | impaired renal function disease | Shionogi | Completed | No outcome recorded |
| Phase 1 | NCT07011992 | Jul 2025 | — | Shionogi | Completed | No outcome recorded |
| Phase 1 | NCT04044781 | Jan → Apr 2020 | — | Tetra Discovery Partners | Withdrawn | No outcome recorded |
| Phase 1 | NCT03030105 | Jan → May 2017 | Alzheimer disease | Tetra Discovery Partners | Completed | No outcome recorded |
| Phase 1 | NCT02840279 | Jun → Nov 2016 | Alzheimer disease | Tetra Discovery Partners | Completed | No outcome recorded |
| Phase 1 | NCT02648672 | Dec 2015 → Feb 2016 | Alzheimer disease | Tetra Discovery Partners | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03861000 | Mar 2019 → Feb 2020 | depressive disorder | National Institute of Mental Health (NIMH) | Completed | No outcome recorded |
| Phase 23 trials · 1 met primary | ||||||
| Phase 2 | NCT06717438 | May 2025 → Dec 2027 expected | — | Shionogi | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03817684 | Apr 2019 → Feb 2020 | Alzheimer disease | Tetra Discovery Partners | Completed | No outcome recorded |
| Phase 2 | NCT03569631 | Jul 2018 → Jul 2020 | fragile X syndrome | Tetra Discovery Partners | Completed | Met primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT05367960 | Nov 2022 → Sep 2027 expected | fragile X syndrome | Tetra Discovery Partners | Active not recruiting | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 2/3 | NCT05163808 Comparator | Mar 2022 → Sep 2025 | fragile X syndrome | Tetra Discovery Partners | Completed | No outcome recorded |
| Phase 3 | NCT05358886 Comparator | Nov 2022 → Jul 2025 | fragile X syndrome | Tetra Discovery Partners | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2024-04-11 | Shionogi | Regulatory The European Commission Grants Orphan Medicinal Product Designation for Zatolmilast, a Potential First-In-Class Treatment Being Investigated for Fragile X Syndrome shionogi.com ↗
the European Commission has granted Orphan Medicinal Product designation for zatolmilast (BPN14770), an investigational treatment for Fragile X syndrome (FXS) |
| 2023-09-27 | Shionogi | Regulatory Zatolmilast, an Investigational Treatment for Fragile X Syndrome, Receives Rare Pediatric Disease Designation from the U.S. FDA shionogi.com ↗ |
| 2020-11-02 | Shionogi | Results Shionogi Announces Positive Topline Results from Phase 2 Study of BPN14770, a Drug Candidate for the Treatment of Brain Disorders Associated with Cognitive and Memory Deficits, in Patients with Fragile X Syndrome shionogi.com ↗
Regarding the primary endpoints of safety and tolerability, all subjects (30 patients) completed both treatment periods and BPN14770 demonstrated excellent safety and tolerability. |
All press releases naming this drug 3 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | zatolmilast | “BPN14770/ zatolmilast” NCT05358886 ↗ |
| Known as | BPN14770 | “Zatolmilast/ BPN14770” NCT05367960 ↗ |
| Action | Inhibit | “negative allosteric modulator of phosphodiesterase 4D” NCT02648672 ↗ |
| Modality | Small molecule | “BPN14770 is a small molecule, subtype selective, negative allosteric modulator of phosphodiesterase 4D.” NCT02648672 ↗ |
| Route | Oral | “single oral dose of BPN14770” NCT02648672 ↗ |
| Target | PDE4D | “modulator of phosphodiesterase 4D” NCT02648672 ↗ |