PRT-064040 / Sichuan Purity Pharmaceutical Technology - LARVOL DELTA

PRT-064040: A nasal spray of novel, potent, and selective calcitonin gene-related peptide receptor antagonist for migraine. (PubMed, J Pharmacol Exp Ther) - "SIGNIFICANCE STATEMENT: This study demonstrates that PRT-064040 is a competitive antagonist exhibiting high affinity, potency, and selectivity for the human calcitonin gene-related peptide receptor. Its rapid absorption at low doses may not only facilitate a fast-onset action but also suggest a potential for reduced adverse events in clinical practice."

Journal • CNS Disorders • Endometriosis • Gynecology • Immunology • Migraine • Oncology • Pain • Women's Health

Safety, tolerability, and pharmacokinetics of PRT-064040 nasal spray following single and multiple ascending doses in healthy adults: A phase 1 study (AHS 2026) - "In this phase 1 study, PRT-064040 nasal spray demonstrated favorable safety, tolerability, and pharmacokinetic characteristics in healthy adults, with no taste-related adverse events commonly associated with nasal formulations. Rapid absorption and expected exposure for efficacy at ≥1 mg support further clinical evaluation of PRT-064040 nasal spray for the acute treatment of migraine, with potential for faster onset of action and improved local tolerability. Collectively, these findings suggest that PRT-064040 nasal spray may offer a fast-acting and well-tolerated acute treatment option for patients with migraine, with the potential to deliver meaningful clinical benefit."

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

Phase II Trial of PRT-064040 Nasal Spray for the Treatment of Migraine in Adults (clinicaltrials.gov) - P2 | N=456 | Recruiting | Sponsor: Sichuan Purity Pharmaceutical Technology Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Migraine • Pain

Phase II Trial of PRT-064040 Nasal Spray for the Treatment of Migraine in Adults (clinicaltrials.gov) - P2 | N=456 | Not yet recruiting | Sponsor: Sichuan Purity Pharmaceutical Technology Co., Ltd.

New P2 trial • CNS Disorders • Migraine • Pain

A Study to Learn About PRT-064040 Nasal Spray in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=80 | Completed | Sponsor: Sichuan Purity Pharmaceutical Technology Co., Ltd. | Recruiting ➔ Completed

Trial completion • CNS Disorders • Migraine • Pain

A Study to Learn About PRT-064040 Nasal Spray in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Sichuan Purity Pharmaceutical Technology Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Migraine • Pain

A Study to Learn About PRT-064040 Nasal Spray in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=80 | Not yet recruiting | Sponsor: Sichuan Purity Pharmaceutical Technology Co., Ltd.

New P1 trial • CNS Disorders • Migraine • Pain