Pharmasaga's PS1 Phase 1 completes with no posted results after 1,614 days
The Taiwan trial cleared completion four years after first-in-human start, but ClinicalTrials.gov shows no posted safety, PK, or dose-escalation data yet.
Executive Summary
- NCT05176210 flipped from Unknown status to Completed on 2026-07-07, with enrollment finalized at 75 subjects, closing out a first-in-human Phase 1 study of PS1 in Type 2 Diabetes Mellitus that started in December 2023. That closes the operational chapter but opens the data chapter: no result has been disclosed.
- The primary completion date moved three separate times, from December 2022 to December 2023 to June 2024 to July 2025 before landing at April 2026, a shift the registry's own risk model flags as 1,243 cumulative delay days. That pattern matters because it shows a small, single-country trial repeatedly missing its own projected timeline before finally closing.
- ClinicalTrials.gov shows no results posted for the primary endpoint, incidence of dose-limiting toxicity and maximum tolerated dose, or for any of the pharmacokinetic and glucose-control secondary endpoints. Until Pharmasaga or a downstream disclosure posts that data, investors cannot judge whether PS1 cleared its safety bar or what dose will move into later development.
- PS1's target and mechanism are unclassified, so it cannot be benchmarked against the 32 identified competitors in the T2DM landscape, most of which use GLP-1 receptor agonism or SGLT2 inhibition. That absence limits how much this readout, once posted, will inform any named rival program.
What changed
The registry record for NCT05176210 shows two changes on 2026-07-07: status moved from Unknown status to Completed, and enrollment count was finalized at 75, up from 64. The trial had briefly lapsed into Unknown status on 2026-04-30, a designation ClinicalTrials.gov applies when a sponsor's status has not been reconfirmed near its expected completion date. That the trial reappeared as Completed just over two months later, with enrollment revised upward, suggests the lapse reflected an administrative reporting gap rather than a halt to the study, though the dossier does not confirm this directly.
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
The design
This is a first-in-human, randomized, double-blind, placebo-controlled study for six of its eight cohorts, with two open-label single-ascending-dose cohorts in Type 2 Diabetes Mellitus patients who receive PS1 without a placebo comparator. The primary endpoint, incidence of dose-limiting toxicity and the maximum tolerated dose, is a safety endpoint: it establishes whether PS1 can be dosed safely at escalating levels, not whether it lowers blood glucose. Secondary endpoints capture pharmacokinetics and, in the two multiple-ascending-dose cohorts of Type 2 Diabetes Mellitus patients, exploratory changes in fasting glucose, postprandial glucose, and HbA1c. A completed status on this design tells investors the dosing and safety observation period is over; it does not by itself tell them the drug worked or was safe at the tested doses.
The timing history
The trial's primary completion date shifted three times over its life: from December 2022 to December 2023 in September 2022, from December 2023 to June 2024 in December 2023, and from June 2024 to July 2025 in April 2024, before ultimately landing at April 27, 2026. Protocol stability tooling labels this a 'Moderate' stability profile with five total change events and 1.33 changes per year, while the trial's own risk assessment separately flags it as critical, citing 1,243 cumulative delay days. Repeated slippage in a small, single-site Phase 1 study is not unusual, but the magnitude here, more than three years beyond the original completion target, is a data point on execution, not a signal on the drug itself.
What is missing
ClinicalTrials.gov confirms no results have been posted for this trial. That means the central clinical questions, whether PS1 cleared its dose-limiting toxicity bar, what maximum tolerated dose was established, and whether the two T2DM multiple-ascending-dose cohorts showed any signal on fasting glucose or HbA1c, remain unanswered. The trial's mechanism and target are also unclassified, which limits how any eventual result will read through to the 32 other T2DM-indication trials in the landscape, most of which pursue GLP-1 receptor agonism or SGLT2 inhibition, mechanisms unrelated to PS1's undisclosed target.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.