pumecitinib nasal spray (PG-011 nasal spray) / PrimeGenX Therapeutics - LARVOL DELTA

A Study to Assess the Efficacy and Safety of PG-011 Nasal Spray in Adults With Moderate to Severe Seasonal Allergic Rhinitis (clinicaltrials.gov) - P2 | N=179 | Completed | Sponsor: Prime Gene Therapeutics Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Allergic Rhinitis • Immunology • Inflammation

Efficacy, safety, and pharmacokinetics of pumecitinib nasal spray for moderate-to-severe seasonal allergic rhinitis: a multicentre, double-blind, randomised, placebo-controlled, phase 2 trial. (PubMed, Lancet Reg Health West Pac) - P2 | "This provides proof of concept for topical JAK inhibition in SAR, warranting larger trials. PrimeGenX Therapeutics Co., Ltd."

Journal • P2 data • PK/PD data • Allergic Rhinitis • Conjunctivitis • Immunology • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology

PrimeGenX Therapeutics…made an initial public offering (IPO) filing to the Hong Kong Stock Exchange (flcube.com) - "The filing covers its core product, pumecitinib (G‑011), a locally delivered JAK inhibitor in gel and nasal spray formulations, along with a pipeline targeting atopic dermatitis, allergic rhinitis, and other autoimmune conditions."

Commercial • Allergic Rhinitis • Atopic Dermatitis

A Phase III Study to Assess the Efficacy and Safety of PG-011 Nasal Spray in Adults With Moderate to Severe Seasonal Allergic Rhinitis (clinicaltrials.gov) - P3 | N=600 | Not yet recruiting | Sponsor: Prime Gene Therapeutics Co., Ltd.

New P3 trial • Allergic Rhinitis • Immunology • Inflammation

A Study to Assess the Efficacy and Safety of PG-011 Nasal Spray in Adults with Moderate to Severe Seasonal Allergic Rhinitis (ChiCTR) - P2/3 | N=760 | Recruiting | Sponsor: Beijing Tongren Hospital, Capital Medical University; Beijing Tongren Hospital, Capital Medical University | Phase classification: P2 ➔ P2/3 | N=160 ➔ 760

Enrollment change • Phase classification • Allergic Rhinitis • Immunology • Inflammation

A dose-exploratory Phase II clinical study to study the safety, efficacy, and pharmacokinetic profile of PG-011 nasal spray in moderate-to-severe seasonal allergic rhinitis (ChiCTR) - P2 | N=160 | Completed | Sponsor: Beijing Tongren Hospital, Capital Medical University; Beijing Tongren Hospital, Capital Medical University | Recruiting ➔ Completed

Trial completion • Allergic Rhinitis • Immunology • Inflammation

Safety and pharmacokinetics of PG-011 nasal spray (ChiCTR) - P1 | N=90 | Completed | Sponsor: Shulan (Hangzhou) Hospital; Shulan (Hangzhou) Hospital | Not yet recruiting ➔ Completed | N=150 ➔ 90

Enrollment change • Trial completion • Allergic Rhinitis • Immunology • Inflammation

A Study to Assess the Efficacy and Safety of PG-011 Nasal Spray in Adults With Moderate to Severe Seasonal Allergic Rhinitis (clinicaltrials.gov) - P2 | N=160 | Active, not recruiting | Sponsor: Prime Gene Therapeutics Co., Ltd. | Not yet recruiting ➔ Active, not recruiting | Trial completion date: Jan 2026 ➔ May 2026

Enrollment closed • Trial completion date • Allergic Rhinitis • Immunology • Inflammation

A Study to Assess the Efficacy and Safety of PG-011 Nasal Spray in Adults with Moderate to Severe Seasonal Allergic Rhinitis (ChiCTR) - P2 | N=160 | Recruiting | Sponsor: Beijing Tongren Hospital, Capital Medical University; Beijing Tongren Hospital, Capital Medical University

New P2 trial • Allergic Rhinitis • Immunology • Inflammation

Pumecitinib: A Study to Assess the Efficacy and Safety of PG-011 Nasal Spray in Adults With Moderate to Severe Seasonal Allergic Rhinitis (clinicaltrials.gov) - P2 | N=160 | Not yet recruiting | Sponsor: Prime Gene Therapeutics Co., Ltd.

New P2 trial • Allergic Rhinitis • Immunology • Inflammation