Ozmosi | Zatolmilast Drug Profile

Product Description

BPN14770, a novel agent that selectively inhibits phosphodiesterase-4D (PDE4D), is designed to enhance early and late stages of memory formation and to potentially improve cognition and memory in central nervous system (CNS) disorders including AD.

Mechanisms of Action: PDE4d Inhibitor

Novel Mechanism: Yes

Modality: Small Molecule

Route of Administration: Oral

FDA Designation: *

Approval Status: Not Approved

Approved Countries: None

Approved Indications: None

Company: Tetra Discovery Partners
Company Location: Eastern America
Company Founding Year: 2011
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Zatolmilast

Countries in Clinic: Japan, United States

Active Clinical Trial Count: 9

Recent & Upcoming Milestones

Highest Development Phases

Phase 3: Fragile X Syndrome

Phase 2: Alzheimer Disease|Other

Phase 1: Breast Cancer|Healthy Volunteers|Kidney Diseases

Trial ID	Trial	Phase	Trial Status	Disease	Primary Completion Date	Probability of Success	Latest Trial Update Date	Data Updated
jRCT2031250224	jRCT2031250224	P1	Recruiting	Alzheimer Disease	2026-10-31
NCT07012005	2415A4113	P1	Completed	Kidney Diseases	2025-12-15		2026-02-28
NCT07011992	2413A4111	P1	Completed	Breast Cancer	2025-07-31		2025-08-15	Patient Enrollment\|Primary Endpoints\|Treatments\|Trial Status
NCT06717438	Jordan's Syndrome [JS]	P2	Active, not recruiting	Other	2027-12-31	12%	2026-06-10	Primary Endpoints
NCT05367960	BPN14770-CNS-302	P3	Active, not recruiting	Fragile X Syndrome	2027-09-30		2025-10-04
jRCT2031210149	jRCT2031210149	P2	Active, not recruiting	Alzheimer Disease	2023-08-31
NCT05358886	BPN14770-CNS-301	P3	Completed	Fragile X Syndrome	2025-07-18	25%	2025-07-24	Primary Endpoints
NCT07018492	2414A4112	P1	Completed	Healthy Volunteers	2025-11-26		2026-02-28	Primary Completion Date\|Primary Endpoints\|Study Completion Date\|Treatments\|Trial Status
NCT05163808	BPN14770-CNS-204	P3	Completed	Fragile X Syndrome	2025-09-02	9%	2026-02-05	Primary Completion Date\|Primary Endpoints\|Study Completion Date\|Treatments\|Trial Status

Recent News Events

Date	Type	Title
02/04/2025	News Article	Shionogi and Jordan's Guardian Angels Announce First-Ever Human Drug Study for Jordan's Syndrome, an Ultra-Rare Genetic Neurodevelopmental Disorder
07/18/2024	News Article	Shionogi Provides Updates on Zatolmilast, an Investigational Drug for Fragile X Syndrome, Including Recent Changes to Study Protocol to Increase Access for Participants and Families
09/27/2023	News Article	Zatolmilast, an Investigational Treatment for Fragile X Syndrome, Receives Rare Pediatric Disease Designation from the U.S. FDA
07/12/2022	News Article	Tetra Therapeutics Initiates Phase 2b/3 Clinical Studies of Investigational Drug BPN14770 in Fragile X Syndrome

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Zatolmilast

Alternative Names: Zatolmilast, bpn-14770, bpn14770, bpn 14770, S898270, S 898270, S-898270 Clinical Status: Active Latest Update: 2026-06-09 Latest Update Note: Clinical Trial Update