SR419
/ Shanghai SIMR Biotech
- LARVOL DELTA
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July 28, 2025
Quantitative Sensory Testing of SR419, a First-in-Class Oral α5-GABAA Receptor Negative Allosteric Modulator, in Neuropathic Pain Patients
(PAINWeek 2025)
- P1, P1/2 | "Participants had a mean age of 66.8 ± 9.31 years (range: 50-81 years), w ith 80% being male . Following administration of a single dose of SR419 (20 mg), pregabalin (150 mg or 300 mg), or placebo to patients with DPN (n = 10), PHN (n = 6), or idiopathic neuropathy (n=8), no significant differences were observed in QST components (DMA, MDT, MPT, WDT, CDT, HPT, CPT) or the overall QST score (△QST) at the affected area across treatment groups, based on parameters including absolute value, E max , and AUC. SR419 and pregabalin exhibited similar effect profiles on QST parameters, although pregabalin demonstrated greater efficacy than SR419 at the affected site."
Clinical • Addiction (Opioid and Alcohol) • CNS Disorders • Musculoskeletal Pain • Neuralgia • Pain • Peripheral Neuropathic Pain
August 09, 2025
Synthesis and evaluation of a novel inhibitor for the α5-GABAA receptor in the treatment of peripheral neuralgia: Evidence from MD simulation and in vivo studies.
(PubMed, Br J Pharmacol)
- "SR-419 is a peripherally acting GABRA5 inhibitor with potent analgesic efficacy and a favourable safety profile. Its target-specific mechanism suggests that it is a promising candidate for treating PNP and avoiding central side effects."
Journal • Preclinical • Anesthesia • Neuralgia • Pain • Peripheral Neuropathic Pain
November 29, 2024
A Phase 1b Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SR419
(clinicaltrials.gov)
- P1/2 | N=24 | Completed | Sponsor: Shanghai SIMR Biotechnology Co., Ltd. | Phase classification: P1b ➔ P1/2
Phase classification • Neuralgia • Pain • Peripheral Neuropathic Pain
March 21, 2023
To Evaluate the Efficacy and Safety of SR419 in Patients With Postherpetic Neuralgia (PHN)
(clinicaltrials.gov)
- P2 | N=83 | Completed | Sponsor: Shanghai SIMR Biotechnology Co., Ltd. | Active, not recruiting ➔ Completed
Trial completion • Neuralgia • Pain
November 30, 2022
To Evaluate the Efficacy and Safety of SR419 in Patients With Postherpetic Neuralgia (PHN)
(clinicaltrials.gov)
- P2 | N=83 | Active, not recruiting | Sponsor: Shanghai SIMR Biotechnology Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2023 ➔ Jan 2023
Enrollment closed • Trial completion date • Neuralgia • Pain
August 25, 2022
Opposite Effects of Src Family Kinases on YAP and ERK Activation in Pancreatic Cancer Cells: Implications for Targeted Therapy.
(PubMed, Mol Cancer Ther)
- "Here, we show that a combination of insulin and the GPCR agonist neurotensin induced rapid activation of Src family of tyrosine kinases (SFKs) within PANC-1 cells, as shown by FAK phosphorylation at Tyr576/577 and Tyr861, sensitive biomarkers of SFK activity within intact cells and Src419 autophosphorylation. Crucially, SFKs promoted YAP nuclear localization and phosphorylation at Tyr357, as shown by using the SFK inhibitors dasatinib, saracatinib, the preferential YES1 inhibitor CH6953755, short interfering RNA (siRNA)-mediated knockdown of YES1 and transfection of epitogue-tagged YAP mutants in PANC-1 and MiaPaCa-2 cancer cells, models of the aggressive squamous subtype of PDAC...A combination of dasatinib and trametinib potently and synergistically inhibited colony formation by PDAC cells and suppessed the growth of MiaPaCa-2 cells xenografted into the flank of nude mice. The results provide rationale for considering a combination(s) of FDA-approved SFK (dasatinib)..."
Journal • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • IGF1
August 05, 2022
A Phase 1b Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SR419
(clinicaltrials.gov)
- P1b | N=24 | Completed | Sponsor: SIMR (Australia) Biotech Pty Ltd. | Recruiting ➔ Completed | Trial completion date: Dec 2021 ➔ Jul 2022 | Trial primary completion date: Dec 2021 ➔ May 2022
Trial completion • Trial completion date • Trial primary completion date • Neuralgia • Pain • Peripheral Neuropathic Pain
August 03, 2022
The Pharmacokinetics (PK), Safety, Tolerability of SR419 in Healthy Volunteers
(clinicaltrials.gov)
- P1 | N=40 | Completed | Sponsor: Shanghai SIMRD Biotechnology Co., Ltd. | Trial completion date: Dec 2021 ➔ May 2022
Trial completion date
May 31, 2022
To Evaluate the Efficacy and Safety of SR419 in Patients With Postherpetic Neuralgia (PHN)
(clinicaltrials.gov)
- P2 | N=82 | Recruiting | Sponsor: Shanghai SIMR Biotechnology Co., Ltd. | Not yet recruiting ➔ Recruiting
Enrollment open • Neuralgia • Pain
May 03, 2022
To Evaluate the Efficacy and Safety of SR419 in Patients With Postherpetic Neuralgia (PHN)
(clinicaltrials.gov)
- P2 | N=82 | Not yet recruiting | Sponsor: Shanghai SIMR Biotechnology Co., Ltd.
New P2 trial • Neuralgia • Pain
March 02, 2022
The Pharmacokinetics (PK), Safety, Tolerability of SR419 in Healthy Volunteers
(clinicaltrials.gov)
- P1 | N=40 | Completed | Sponsor: Shanghai SIMRD Biotechnology Co., Ltd. | Recruiting ➔ Completed
Trial completion
August 31, 2021
The Pharmacokinetics (PK), Safety, Tolerability of SR419 in Healthy Volunteers
(clinicaltrials.gov)
- P1; N=32; Recruiting; Sponsor: Shanghai SIMRD Biotechnology Co., Ltd.; Not yet recruiting ➔ Recruiting
Clinical • Enrollment open
August 19, 2021
The Pharmacokinetics (PK), Safety, Tolerability of SR419 in Healthy Volunteers
(clinicaltrials.gov)
- P1; N=32; Not yet recruiting; Sponsor: Shanghai SIMRD Biotechnology Co., Ltd.
Clinical • New P1 trial
August 18, 2021
A Phase 1b Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SR419
(clinicaltrials.gov)
- P1b; N=24; Recruiting; Sponsor: SIMR (Australia) Biotech Pty Ltd.; Trial completion date: Jun 2021 ➔ Dec 2021; Trial primary completion date: Jun 2021 ➔ Dec 2021
Clinical • Trial completion date • Trial primary completion date • Neuralgia • Pain • Peripheral Neuropathic Pain
March 25, 2021
A Study to Assess the Pharmacokinetics and Food Effect of SR419 in Healthy Subjects
(clinicaltrials.gov)
- P1; N=24; Completed; Sponsor: SIMR (Australia) Biotech Pty Ltd; Recruiting ➔ Completed
Clinical • Trial completion
March 02, 2021
A Study to Assess the Pharmacokinetics and Food Effect of SR419 in Healthy Subjects
(clinicaltrials.gov)
- P1; N=24; Recruiting; Sponsor: SIMR (Australia) Biotech Pty Ltd; Not yet recruiting ➔ Recruiting
Clinical • Enrollment open
January 12, 2021
A Study to Assess the Pharmacokinetics and Food Effect of SR419 in Healthy Subjects
(clinicaltrials.gov)
- P1; N=24; Not yet recruiting; Sponsor: SIMR (Australia) Biotech Pty Ltd
Clinical • New P1 trial
December 03, 2020
A Phase 1b Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SR419
(clinicaltrials.gov)
- P1b; N=24; Recruiting; Sponsor: SIMR (Australia) Biotech Pty Ltd; Trial completion date: Jan 2021 ➔ Jun 2021; Trial primary completion date: Jan 2021 ➔ Jun 2021
Clinical • Trial completion date • Trial primary completion date • Neuralgia • Pain • Peripheral Neuropathic Pain
October 13, 2020
A Phase 1b Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SR419
(clinicaltrials.gov)
- P1b; N=24; Recruiting; Sponsor: SIMR (Australia) Biotech Pty Ltd; Not yet recruiting ➔ Recruiting
Clinical • Enrollment open • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain
September 20, 2020
Key Milestone: The first patient successfully dosed with the candidate drug SR419 for peripheral neuropathic pain
(PRNewswire)
- "Shanghai SIMR Biotechnology Co., Ltd....announced that, the clinical trial in patients with peripheral neuropathic pain has been initiated for the candidate drug SR419, and the first patient has been successfully dosed. The current clinical trial is the first study for SR419 in the patient population, purposing to explore the efficacy, safety, tolerability and pharmacokinetics of SR419 in patients with neuropathic pain."
New trial • Trial status • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain
August 07, 2020
A Phase 1b Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SR419
(clinicaltrials.gov)
- P1b; N=24; Not yet recruiting; Sponsor: SIMR (Australia) Biotech Pty Ltd
Clinical • New P1 trial • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain
December 12, 2019
The Safety, Tolerability, Pharmacokinetics(PK) of SR419 in Healthy Volunteers
(clinicaltrials.gov)
- P1; N=64; Completed; Sponsor: SIMR (Australia) Biotech Pty Ltd; Recruiting ➔ Completed
Clinical • Trial completion
September 17, 2019
Chinese chronic pain reliever begins clinical trial
(xinhuanet)
- "A new Chinese drug to alleviate patients' neuropathic pain, or nerve pain, has entered clinical trials, according to the Ministry of Science and Technology Tuesday....Data shows that the incidence of neuropathic pain among Chinese elderly is 49.8 percent and more than 50 percent in cancer patients. Conventional painkillers are largely ineffective."
New trial
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