Drugs / SPT-300
last change 24 days ago re-read 3 minutes ago

SPT-300

Small molecule

Developed for
major depressive disorder · mixed anxiety and depressive disorder
Investigated by
Premier Research · Seaport Therapeutics

Trials 2

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2 NCT07161700 Sep 2025 → May 2027 expected major depressive disorder Seaport Therapeutics Enrolling by invitation No outcome recorded
Phase 2 NCT07065240 Jun 2025 → Mar 2027 expected major depressive disorder, mixed anxiety and depressive disorder Seaport Therapeutics Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 12

DateIssuerRelease
2026-09-09 PureTech Results PureTech Founded Entity Seaport Therapeutics Reports Positive Topline Results from Phase 1 Driving Simulation Trial of GlyphAllo™ in Healthy Volunteers puretechhealth.com ↗
The trial met its primary endpoint, demonstrating that evening dosing of GlyphAllo at 375 mg did not impair next-morning driving performance compared to placebo on Day 5, following multiple-day dosing.
2026-03-25 Seaport Therapeutics Results Seaport Therapeutics Announces Science Translational Medicine Peer-Reviewed Publication Featuring GlyphAllo (SPT-300) as the First Triglyceride-Mimetic Prodrug to Achieve Therapeutically Relevant Drug Levels in Humans seaporttx.com ↗
The peer-reviewed article, titled “An oral allopregnanolone prodrug bypasses liver metabolism via lymphatic transport enabling bioavailability in animals and humans,” details the design, optimization, and clinical translation of GlyphAllo, and further supports clinical validation of Seaport’s proprietary Glyph™ platform.
2026-03-25 PureTech Results PureTech Founded Entity Seaport Therapeutics Announces Publication in Science Translational Medicine Featuring GlyphAllo™ (SPT-300) as the First Triglyceride-Mimetic Prodrug to Achieve Therapeutically Relevant Drug Levels in Humans puretechhealth.com ↗
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a hub-and-spoke biotherapeutics company dedicated to giving life to science and transforming innovation into value, notes that its Founded Entity, Seaport Therapeutics, today announced the publication of first-in-human clinical and preclinical data for GlyphAllo™ (SPT-300 or Glyph Allopregnanolone) in Science Translational Medicine.
2024-12-11 Seaport Therapeutics Results Seaport Therapeutics Presents Additional Data from Phase 1 Study of SPT-300 at ACNP Annual Meeting 2024 seaporttx.com ↗
SPT-300 was well-tolerated, with all adverse events (AE) being mild or moderate, transient and dose-dependent.
2024-12-11 PureTech Results PureTech Founded Entity Seaport Therapeutics Presents Additional Data from Phase 1 Study of SPT-300 at ACNP Annual Meeting 2024 puretechhealth.com ↗
New data presented at the conference include further safety analyses and pharmacokinetic and pharmacodynamic data.
2024-05-09 Seaport Therapeutics Results Seaport Therapeutics Presents Data from Multiple SPT-300 Trials at Society of Biological Psychiatry (SOBP) Annual Meeting seaporttx.com ↗
In a Phase 2a trial, SPT-300 2 substantially reduced stress-induced levels of cortisol, supporting Seaport’s planned studies in mood and anxiety disorders, including anxious depression
2024-05-09 PureTech Results PureTech Founded Entity Seaport Therapeutics Presents Data from Multiple SPT-300 Trials at Society of Biological Psychiatry (SOBP) Annual Meeting puretechhealth.com ↗
SPT-300 demonstrated nine times greater allopregnanolone exposure in humans dosed orally than published data for oral allopregnanolone, 1 validating Glyph ™ platform's ability to enhance oral bioavailability
2023-11-14 PureTech Results PureTech's LYT-300 (Oral Allopregnanolone) Achieved Primary Endpoint in a Phase 2a Acute Anxiety Trial in Healthy Volunteers puretechhealth.com ↗
2023-02-14 PureTech Results PureTech to Advance LYT-300 (Oral Allopregnanolone) for the Potential Treatment of Anxiety Disorders and Postpartum Depression puretechhealth.com ↗
In a healthy volunteer study, LYT-300 achieved blood levels of allopregnanolone at or above those associated with therapeutic effect in postpartum depression [1] and was generally well-tolerated
2022-12-19 PureTech Results PureTech's LYT-300 (Oral Allopregnanolone) Demonstrates Oral Bioavailability, Tolerability and GABAA Receptor Target Engagement in Healthy Volunteers puretechhealth.com ↗
Topline results announced today show that oral administration of LYT-300 achieved blood levels of allopregnanolone at or above those associated with therapeutic benefit 1 and resulted in exposure-dependent target engagement with γ-aminobutyric-acid type A (GABA A ) receptors.
2022-06-14 PureTech Results PureTech Meets Milestone of Achieving Oral Bioavailability of Allopregnanolone in Healthy Adults Dosed with LYT-300 puretechhealth.com ↗
LYT-300 achieved systemic blood levels approximately nine-fold greater compared to previous reports with oral allopregnanolone.
2021-12-08 PureTech Results PureTech Presents Preclinical Proof-of-Concept Data for LYT-300 (Oral Allopregnanolone) as Potential Treatment for Neurological and Neuropsychological Conditions puretechhealth.com ↗

All press releases naming this drug 14 releases

DateIssuerRelease

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as SPT-300 ClinicalTrials.gov intervention name — accepted as the source's own label NCT07161700 ↗
1

NCT07065240 ↗

Modality Small molecule “A prodrug of allopregnanolone, a small molecule drug” NCT07065240 ↗
Route Oral “Participants will receive SPT-300 capsules once daily for 42 days” NCT07161700 ↗