SR750 / Shanghai SIMR Biotech - LARVOL DELTA

Safety and Efficacy of SR750 in Patients with Trigeminal Neuralgia: A Double-Blind, Randomized, Placebo-controlled, Phase 2 Study (EAN 2026) - P2 | "Overall, SR750 low dose and high dose demonstrated statistically and clinically significant efficacy versus placebo, with a favorable safety and tolerability profile, supporting its further investigation in late-stage trials."

Clinical • Late-breaking abstract • P2 data • Neuralgia • Pain

Efficacy, Safety, and Tolerability of SR750 in Patients With Trigeminal Neuralgia (clinicaltrials.gov) - P2 | N=138 | Completed | Sponsor: Shanghai SIMR Biotechnology Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Neuralgia • Pain

Efficacy, Safety, and Tolerability of SR750 in Patients With Trigeminal Neuralgia (clinicaltrials.gov) - P2 | N=138 | Active, not recruiting | Sponsor: Shanghai SIMR Biotechnology Co., Ltd. | Not yet recruiting ➔ Active, not recruiting | Trial completion date: Nov 2025 ➔ Feb 2026 | Trial primary completion date: Oct 2025 ➔ Jan 2026

Enrollment closed • Trial completion date • Trial primary completion date • Neuralgia • Pain

The Pharmacokinetics (PK), Safety, Tolerability of SR750 (Formulation F1) in Healthy Volunteers (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: Shanghai SIMR Biotechnology Co., Ltd. | Not yet recruiting ➔ Completed

Trial completion

The Pharmacokinetics (PK), Safety, Tolerability of SR750 (Prescription F1) in Healthy Volunteers (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Shanghai SIMR Biotechnology Co., Ltd.

New P1 trial

Efficacy, Safety, and Tolerability of SR750 in Patients With Trigeminal Neuralgia (clinicaltrials.gov) - P2 | N=162 | Not yet recruiting | Sponsor: Shanghai SIMR Biotechnology Co., Ltd.

New P2 trial • Neuralgia • Pain

The Pharmacokinetics (PK), Safety, Tolerability of SR750 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=56 | Completed | Sponsor: Shanghai SIMR Biotechnology Co., Ltd. | Recruiting ➔ Completed | N=40 ➔ 56

Enrollment change • Trial completion

The Pharmacokinetics (PK), Safety, Tolerability of SR750 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Shanghai SIMR Biotechnology Co., Ltd.

New P1 trial

The Safety, Tolerability, and Pharmacokinetics (PK) of SR750 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=83 | Completed | Sponsor: SIMR (Australia) Biotech Pty Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Mar 2023 ➔ Oct 2022 | Trial primary completion date: Mar 2023 ➔ Oct 2022

Trial completion • Trial completion date • Trial primary completion date

The Safety, Tolerability, and Pharmacokinetics (PK) of SR750 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=83 | Active, not recruiting | Sponsor: SIMR (Australia) Biotech Pty Ltd. | Trial primary completion date: Dec 2022 ➔ Mar 2023

Trial primary completion date

The Safety, Tolerability, and Pharmacokinetics (PK) of SR750 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=83 | Active, not recruiting | Sponsor: SIMR (Australia) Biotech Pty Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2022 ➔ Mar 2023

Enrollment closed • Trial completion date