QRL-101 / QurAlis - LARVOL DELTA

A Multiple Ascending Dose Study Evaluating the Safety and Tolerability of a Novel Formulation of QRL-101 in Healthy Participants (clinicaltrials.gov) - P1 | N=48 | Active, not recruiting | Sponsor: QurAlis Corporation | Recruiting ➔ Active, not recruiting

Enrollment closed

Results From QRL-101-04: Evidence Of Target Engagement With A Selective Kv7.2/7.3 Ion Channel Opener In ALS Patients (ENCALS 2026) - "The findings are consistent with results from the QRL-101-05 study in healthy volunteers, with approximately a 3-fold greater change in magnitude. These results support the further study of QRL-101 to establish the relationship with Kv7.2/7.3 enhancement, and thus hyperexcitability reduction, on disease progression in ALS."

Clinical

Results From QRL-101-05: Proof Of Kv7.2/7.3 Peripheral And Cortical Excitability Modulation After A Single Dose At Two At Two Dose Levels Of QRL-101 In A 3-Way Cross Over Design Ph1 Healthy Volunteer Study. (ENCALS 2026) - "Biomarkers assessed through mNETT and TMS-EMG indicate evidence of QRL-101 brain penetration, target engagement, and PoM. Results of QRL-101-05 support continued development of QRL-101 in ALS."

Clinical • CNS Disorders • Epilepsy

QRL-101-08: A Study Evaluating the Safety and Tolerability of a Novel Formulation of QRL-101 in Healthy Participants (clinicaltrialsregister.eu) - P1 | N=48 | Recruiting | Sponsor: Quralis Corp.

New P1 trial • CNS Disorders • Epilepsy • Pain

A Multiple Ascending Dose Study Evaluating the Safety and Tolerability of a Novel Formulation of QRL-101 in Healthy Participants (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: QurAlis Corporation

New P1 trial

QurAlis Confirms Signal of Target Engagement in ALS Patients in Phase 1 Clinical Trial of QRL-101, a Potentially Best-in-Class Selective Kv7.2/7.3 Ion Channel Opener (Businesswire) - "QurAlis intends to advance QRL-101 into Phase 2 proof-of-concept clinical trials as a potentially best-in-class treatment for both DEE and ALS...Results showed reduced motor-neuron hyperexcitability compared to placebo, with a more robust response being observed in patients with higher exposure to QRL-101. In addition, there was a consistent, expected directional change across multiple measures including strength-duration time constant (SDTC), rheobase, and eight of the nine additional measures evaluated as part of the motor nerve excitability threshold tracking (mNETT) assessment...Results also demonstrated that the pharmacokinetic (PK), safety, and tolerability profile of QRL-101 was consistent with previously reported study results evaluating QRL-101."

New P2 trial • P1 data • Amyotrophic Lateral Sclerosis • Epilepsy

QRL-101-05: A Phase 1 Study to Evaluate Cortical and Motor Nerve Excitability in Healthy Volunteers Following Administration of the KCNQ7.2/7.3 Modulator QRL-101 (AES 2025) - P1 | "Biomarkers assessed through TMS-EMG, TMS-EEG, and pEEG indicate evidence of QRL-101 brain penetration, target engagement, and potential anti-seizure effects. Little to no effects on delta/theta waves coupled with no related AEs for somnolence suggest that selectivity for Kv7.2/7.3 against the GABA-A receptor, Kv7.4 channel and Kv7.3/7.5 channel is an effective strategy to improve tolerability of a Kv7.2/7.3 opener without decreasing efficacy. Results of QRL-101-05 support continued development of QRL-101 to a Phase 2 study in epilepsy (NCT06681441)."

Clinical • P1 data • CNS Disorders • Epilepsy

QRL-101 – phase 1 studies evaluating safety and pharmacodynamics of a kcnq2/3 modulator in healthy volunteers & next steps for development in ALS (ALS-MND 2025) - "Results of these studies support initiation of a Phase 2 POC study in ALS, planned for the near future. A safe and tolerable dose range has been determined. Reducing motor system hyperexcitability is a potential therapeutic strategy in ALS."

Clinical • P1 data • PK/PD data • CNS Disorders

QRL-101 – PHASE 1 STUDIES EVALUATING SAFETY AND PHARMACODYNAMICS OF A KCNQ2/3 MODULATOR IN HEALTHY VOLUNTEERS & NEXT STEPS FOR DEVELOPMENT IN ALS (PACTALS 2025) - "These endpoints may be scalable to other, larger, multi-center, global clinical trials. Findings from these studies will be used to advance the development of QRL-101 in ALS and other neurodegenerative diseases."

Clinical • P1 data • PK/PD data • CNS Disorders

QurAlls Pipeline And Development Updates For QRl-101 And QRL-201 In ALS (PACTALS 2025) - "Sponsored by QurAlis Corporation"

QRL-101-04: A Study Exploring the PK/PD Relationship of QRL-101 in Adults With ALS (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: QurAlis Corporation | Recruiting ➔ Completed

Trial completion • Amyotrophic Lateral Sclerosis • CNS Disorders

QRL-101-06: A Study Evaluating the Pharmacokinetics of Three QRL-101 Formulations in Healthy Participants (clinicaltrials.gov) - P1 | N=25 | Completed | Sponsor: QurAlis Corporation | Active, not recruiting ➔ Completed

Trial completion

QRL-101-06: A Study Evaluating the Pharmacokinetics of Three QRL-101 Formulations in Healthy Participants (clinicaltrials.gov) - P1 | N=25 | Active, not recruiting | Sponsor: QurAlis Corporation | Recruiting ➔ Active, not recruiting

Enrollment closed

QRL-101-04: A Study Exploring the PK/PD Relationship of QRL-101 in Adults With ALS (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: QurAlis Corporation | Trial primary completion date: Mar 2025 ➔ Nov 2025

Trial primary completion date • Amyotrophic Lateral Sclerosis • CNS Disorders

QurAlis Announces Topline Data From its Phase 1 Clinical Trial of QRL-101 Evaluating Biomarkers of ALS and Epilepsy in Healthy Volunteers (PRNewswire) - P1 | N=24 | NCT06681441 | Sponsor: QurAlis Corporation | "QurAlis Corporation...today announced positive topline data from QurAlis' Phase 1 proof-of-mechanism (PoM) clinical trial of QRL-101 in healthy volunteers evaluating biomarkers related to amyotrophic lateral sclerosis (ALS) and epilepsy. Topline results demonstrated a dose-dependent, statistically significant decrease in motor nerve excitability threshold tracking (mNETT) strength-duration time constant (SDTC), the co-primary endpoint of the trial related to ALS...The decrease in SDTC observed with QRL-101 in this study was approximately 50% greater than previously reported for the Kv7 potassium channel opener ezogabine in a single-dose study in people with ALS...The study did not reach statistical significance on the co-primary endpoint of TMS-EMG motor evoked potential (MEP) amplitude, another measure of corticospinal excitability."

P1 data • Amyotrophic Lateral Sclerosis • Epilepsy

A Study Evaluating the Pharmacokinetics of Three QRL-101 Formulations in Healthy Participants (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: QurAlis Corporation

New P1 trial

QRL-101-03: A Study Evaluating Multiple Ascending Doses of QRL-101 in Healthy Participants (clinicaltrials.gov) - P1 | N=60 | Completed | Sponsor: QurAlis Corporation | Recruiting ➔ Completed

Trial completion

A 3-way Cross-over Study on the Effects of QRL-101 on Transcranial Magnetic Stimulation and Nerve Excitability in Healthy Participants (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: QurAlis Corporation | Recruiting ➔ Completed

Trial completion

QurAlis Doses First Patient With ALS in Phase 1 Clinical Trial Evaluating QRL-101, a First-in-Class Kv7 Precision Therapy for ALS (PRNewswire) - "QurAlis Corporation...announced that the first patient with ALS has been dosed in a Phase 1 clinical trial evaluating QRL-101 in people living with ALS (QRL-101-04)....QRL-101-04 (NCT06714396) is a Phase 1 proof-of-mechanism (PoM) single-dose, placebo-controlled clinical trial designed to evaluate the safety and tolerability of QRL-101 in people living with ALS. The study is expected to enroll approximately 12 participants with ALS and will evaluate the impact of QRL-101 on excitability biomarkers including on the strength-duration time constant (SDTC), a known predictor of survival in ALS patients....QurAlis anticipates reporting topline data from the QRL-101-04 Phase 1 clinical trial in the first half of 2025."

P1 data • Trial status • Amyotrophic Lateral Sclerosis

A Study Exploring the PK/PD Relationship of QRL-101 in Adults With ALS (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: QurAlis Corporation

New P1 trial • Amyotrophic Lateral Sclerosis • CNS Disorders

QRL-101-01 – a single, ascending dose study evaluating safety of a KCNQ2/3 modulator in healthy volunteers and next steps for development in ALS (ALS-MND 2024) - "QRL-101-01 included single doses of QRL-101, from 1 mg to 96 mg, administered via two different methods of administration. QRL-101 was found to be generally safe and well tolerated. Based on preliminary data, the most common reported adverse events were headache and nausea."

Clinical • Amyotrophic Lateral Sclerosis • CNS Disorders • Pain

Development of an exploratory electrophysiology endpoint for use in clinical development in amyotrophic lateral sclerosis (ALS-MND 2024) - "The electrophysiology endpoint is ready for piloting in a clinical trial where altering hyperexcitability is a component of the therapeutic strategy, such as in QurAlis' Kv7.2/7.3 opener, QRL-101 program. ALS is in need of quantitative, clinical outcomes, and this proposed endpoint is scalable to other, and larger, multi-centre, global clinical trials. Use in early phase trials will contribute data for additional phase appropriate pivotal validation studies."

Clinical • Amyotrophic Lateral Sclerosis • CNS Disorders

A 3-way Cross-over Study on the Effects of QRL-101 on Transcranial Magnetic Stimulation and Nerve Excitability in Healthy Participants (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: QurAlis Corporation

New P1 trial

QurAlis Doses First Participant Cohort in Phase 1 Multiple-Ascending Dose (MAD) Clinical Trial Evaluating QRL-101, a First-in-Class Kv7 Precision Therapy for ALS (PRNewswire) - "QurAlis Corporation...announced that the company recently completed dosing of the first participant cohort in the Phase 1 multiple-ascending dose (MAD) clinical trial evaluating QRL-101 (QRL-101-03; NCT06532396)....QRL-101-03 is a randomized, double-blind, placebo-controlled, single-site Phase 1 clinical trial designed to evaluate the safety, tolerability, and pharmacokinetics of multiple-ascending doses of QRL-101 in adult healthy volunteers. The study is expected to enroll approximately 60 participants, who will be randomized in a 9:3 ratio of QRL-101 to placebo into five planned cohorts....QurAlis anticipates reporting topline data from the Phase 1 MAD clinical trial of QRL-101 in the first half of 2025."

P1 data • Trial status • Amyotrophic Lateral Sclerosis

A Study Evaluating Multiple Ascending Doses of QRL-101 in Healthy Participants (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: QurAlis Corporation

New P1 trial