SJP-0132 / Senju Pharmaceutical, Mochida - LARVOL DELTA

Evaluation of the skin carcinogenicity of the TRPV1 antagonist motugivatrep (SJP-0132) using an ultra-short-term two-stage skin carcinogenesis assay in Tg-rasH2 mice. (PubMed, J Toxicol Pathol) - "In contrast, treatment with TPA significantly increased skin tumor formation, confirming the validity of the assay. These results indicated that motugivatrep lacked skin tumor promotion activity in this Tg-rasH2 mice model, providing safety information regarding dermal exposure to motugivatrep."

Journal • Preclinical • Dry Eye Disease • Oncology • Ophthalmology • Skin Cancer • TRPV1

Results of a Randomized, Double-Masked, Placebo-Controlled Phase 1/2 Study of a TRPV1 antagonist SJP-0132 in Participants with Dry Eye Disease. (PubMed, Am J Ophthalmol) - "SJP-0132 was safe and well tolerated, plasma concentrations increased dose dependently, and efficacy data indicated that it improved both signs and symptoms of DED with a rapid onset of improvement."

Journal • P1/2 data • Dry Eye Disease • Ophthalmology • MMP9 • TRPV1

Efficacy and Safety of SJP-0132 in Patients with Dry Eye Disease: A Phase 2b Randomized, Double-Masked, Dose-Finding Study. (PubMed, Am J Ophthalmol) - "SJP-0132 showed generally dose-dependent efficacy and safety. Based on safety and treatment benefits with SJP-0132 0.3% in the overall population and in subgroups, this dose was considered optimal for further development."

Journal • P2b data • Dry Eye Disease • Ophthalmology • TRPV1

Efficacy and Safety of SJP-0132 Eye Drops in Chinese Patients With Dry Eye Disease (clinicaltrials.gov) - P3 | N=427 | Completed | Sponsor: Senju Pharmaceutical Science & Technology (Beijing) Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Dry Eye Disease • Ophthalmology

Efficacy and Safety of SJP-0132 Eye Drops in Chinese Patients With Dry Eye Disease (clinicaltrials.gov) - P3 | N=427 | Active, not recruiting | Sponsor: Senju Pharmaceutical Science & Technology (Beijing) Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Dry Eye Disease • Ophthalmology

SJP-0132, a TRPV1 antagonist in Dry Eye Patients – Results of a Phase 2 Study (ARVO 2025) - "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Clinical • P2 data • Dry Eye Disease • Ophthalmology • TRPV1

Results of non-clinical ocular instillation toxicity studies of SJP-0132, a TRPV1 antagonist, a novel eye drop for dry eye disease (ARVO 2025) - "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Clinical • Dry Eye Disease • Ophthalmology • TRPV1

Effects of a novel TRPV1 antagonist, SJP-0132, on CCL5 expression in corneal epithelial cells (ARVO 2025) - "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Dry Eye Disease • Ophthalmology • CCL5 • TRPV1

Impact of SJP-0132, a novel TRPV1 antagonist, on capsaicin-induced responses in rats (ARVO 2025) - "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Preclinical • Dry Eye Disease • Ophthalmology • TRPV1

Antagonistic activity and selectivity of SJP-0132 against transient receptor potential cation channel subfamily V member 1 (ARVO 2025) - "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Dry Eye Disease • Ophthalmology • TRPM8 • TRPV1

Efficacy and Safety of SJP-0132 Eye Drops in Chinese Patients With Dry Eye Disease (clinicaltrials.gov) - P3 | N=400 | Recruiting | Sponsor: Senju Pharmaceutical Science & Technology (Beijing) Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Dry Eye Disease • Ophthalmology

Efficacy and Safety of SJP-0132 Eye Drops in Treatment of Dry Eye Patients in China (clinicaltrials.gov) - P3 | N=400 | Not yet recruiting | Sponsor: Senju Pharmaceutical Science & Technology (Beijing) Co., Ltd.

New P3 trial • Dry Eye Disease • Ophthalmology

Results of a Randomized, Double-Masked, Placebo-Controlled Phase 1/2 Study of SJP-0132, a TRPV1 Antagonist for DED (AAO 2024) - "This dose dependence was generally consistent among variables. Conclusion SJP-0132 was suggested to be safe, well tolerated and effective on both signs and symptoms of DED."

Clinical • P1/2 data • Dry Eye Disease • Ophthalmology • TRPV1

Safety, PK and Efficacy Study of SJP-0132 in Subjects With Dry Eye Disease (clinicaltrials.gov) - P1/2; N=89; Completed; Sponsor: Senju Pharmaceutical Co., Ltd.; Recruiting ➔ Completed

Clinical • Trial completion • MMP9