Patrys Takes Intravenous Quetiapine Into Human Testing
3 min read
8:57am on Wednesday 23rd of September, 2026 AEST ~8am, 23rd Sept, 26
Patrys has dosed the first participants in the Phase 1a trial of RLS-2202, moving its intravenous quetiapine formulation into human clinical evaluation. The next test comes in October, when an independent safety committee will decide whether the program can advance to Cohort 2.
- First participants dosed in RLS-2202 Phase 1a trial
- Study will assess safety, tolerability and pharmacokinetics
- RLS-2202 targets delirium treatment in acute-care settings
- Cohort 2 material manufactured and undergoing quality testing
- Safety review and potential Cohort 2 dosing targeted for Q4 2026
RLS-2202 Moves Into Human Clinical Testing
Patrys Limited (ASX:PAB) has crossed the most consequential development threshold yet for RLS-2202: the first participants have been dosed in the Phase 1a trial of its proprietary intravenous formulation of quetiapine. The milestone shifts the program from formulation work and trial preparation to the collection of human clinical data.
RLS-2202 is being developed as a potential intravenous treatment for delirium in acute-care settings. Patrys says the formulation is intended to provide an alternate route of administration that could be faster and safer than oral treatment in that setting, although the current study is not designed to demonstrate efficacy.
The Phase 1a trial is taking place in healthy adult volunteers and is primarily focused on safety and tolerability. It will also measure the drug's pharmacokinetic profile and help identify dose levels for later development. In Cohort 1, participants receive both oral quetiapine and RLS-2202, separated by a four-day washout period, allowing the intravenous formulation to be assessed against the established oral product.
October Safety Review Sets Next Decision Point
The trial uses a dose-escalation design, meaning progression is not automatic. An independent Safety Review Committee is scheduled to examine the available Cohort 1 safety data in October before Patrys can move to Cohort 2.
Patrys has completed GMP manufacturing and filling of the clinical trial material required for Cohort 2, but that material still needs to pass quality-control testing and be released for clinical use. Subject to both the safety review and successful release, the company expects to begin Cohort 2 dosing in the fourth quarter of calendar 2026 and remains targeted to dose the final participant in that cohort during the same period.
No safety, tolerability or pharmacokinetic results have been disclosed yet. That leaves the October review and the eventual Cohort 2 data as the first substantive tests of whether RLS-2202 can support the dose selection, regulatory discussions and later trials needed to evaluate intravenous quetiapine in patients with delirium.
Bottom Line?
The first dosing milestone validates entry into the clinic, but the investment case now turns on safety data, dose selection and whether manufacturing release keeps the Cohort 2 timetable intact.
Questions in the middle?
- Will the independent Safety Review Committee clear RLS-2202 to advance beyond Cohort 1?
- Will intravenous administration show a clinically useful pharmacokinetic profile compared with oral quetiapine?
- Can Patrys deliver Cohort 2 dosing in Q4 2026 without delays in quality testing or material release?
