Clinical Trials
26
0 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2015
Completed
23
88.5%
Terminated
3
11.5%
No approval data available
- Allergic rhinoconjunctivitis is an IgE-mediated inflammatory disorder affecting roughly 30% of the population, with a substantial burden among children, adolescents, and younger adults. - The FDA expanded ODACTRA's indication in February 2025 to include children aged five to 11 years, broadening house dust mite immunotherapy access for pediatric patients. - Inmunotek's MM09-MG01 is advancing through a Phase III randomized, placebo-controlled, multicenter trial for house dust mite-induced allergic rhinitis or rhinoconjunctivitis with mild to moderate asthma. - The seven-major-market outlook through 2036 anticipates rising demand driven by increasing prevalence, improved diagnostic awareness, and expanding access to allergen immunotherapy.
- Stallergenes Greer will present 23 abstracts, including debut paediatric phase III YOBI data and updated real-world EfficAPSI findings, at the EAACI 2026 congress in Istanbul. - The YOBI study of 300 IR Birch SLIT-liquid in children aged 5–17 met its primary endpoint with a 41% improvement in ARC total combined score versus placebo (p<0.0001). - The EfficAPSI study, the largest real-world SLIT cohort to date, evaluated over 110,000 treated patients and more than 330,000 comparator patients for asthma onset and progression. - A company-sponsored symposium will explore AIT's disease-modifying potential, immune tolerance, and emerging remission concepts in respiratory allergy.
- Nuance Pharma announced that China's National Medical Products Administration (NMPA) has cleared its IND application for Actair®, enabling a pivotal Phase III clinical trial for house dust mite-induced allergic rhinitis. - The upcoming study will be a randomized, double-blind, placebo-controlled trial evaluating Actair® efficacy and safety over 12 months in patients with allergic rhinitis, with or without concomitant asthma. - Actair® is already commercialized across 21 countries and territories under multiple brand names, with Nuance Pharma having established an exclusive partnership with Stallergenes Greer for Chinese market development. - The IND clearance follows recent milestones including Macau approval in January 2026 and launch in China's Hainan Boao Pilot Zone through an early access program in May 2026.
- Stallergenes Greer announced the acquisition of Entomon s.r.l., the only European company capable of extracting pure Hymenoptera venom for medical use. - The acquisition strengthens manufacturing capabilities for venom immunotherapy treatments, addressing supply constraints in a market with limited global capacity. - Hymenoptera venom allergy is the primary cause of anaphylaxis in adults, responsible for 48.2% of cases in Europe and approximately 72 deaths annually in the United States. - Venom immunotherapy remains the only proven treatment to prevent systemic allergic reactions and modify the natural course of venom allergy.
- Stallergenes Greer's Phase IIIb YOBI study successfully met its primary endpoint, demonstrating a 41% improvement in allergic rhinoconjunctivitis symptoms in children and adolescents treated with Staloral Birch compared to placebo. - The trial enrolled 553 children aged 5-17 years across 64 sites in 12 European countries, showing highly statistically significant results with p<0.0001 for both primary and secondary endpoints. - The positive results complete the company's pediatric development program for Staloral Birch and strengthen evidence for early intervention in treating respiratory allergies in children. - Allergic rhinoconjunctivitis affects more than 500 million people worldwide, with children at higher risk of developing asthma if sensitized at a young age.
- Stallergenes Greer has appointed CEOLIA Pharma as its new promotional partner for Actair® in Japan, ending a 15-year licensing agreement with Shionogi that began in 2010. - Actair® is a sublingual immunotherapy tablet designed to treat patients with house dust mite-induced allergic rhinitis, representing a specialized treatment approach for respiratory allergies. - Shionogi will continue serving as Marketing Authorisation Holder during the transition period, maintaining responsibility for importation, manufacturing, and distribution while providing operational support to CEOLIA. - The partnership change aims to advance access to allergen immunotherapy treatments and improve quality of life for patients with respiratory allergies in Japan.
- The peanut allergy treatment market is projected to grow at a 16% CAGR from 2020-2034, driven by current epinephrine usage, anticipated XOLAIR adoption in adults, PALFORZIA expansion to toddlers, and the expected entry of Viaskin Peanut patches. - DBV Technologies' Viaskin Peanut patch leads the pipeline as a promising non-invasive epicutaneous immunotherapy option, with Phase III VITESSE trial results expected in Q4 2025 and potential BLA submission in the first half of 2026. - The market reached USD 400 million in 2024 across seven major markets, with approximately 9.8 million diagnosed prevalent cases, though only 50% of affected individuals in the US received treatment, highlighting significant care gaps. - Stallergenes Greer launched PALFORZIA for toddlers aged 1-3 years in February 2025, while the FDA approved OMLYCLO as the first interchangeable biosimilar for XOLAIR in March 2025.
- The European Commission has approved Palforzia for treating peanut allergies in toddlers aged 1-3, expanding its availability in Europe. - This approval follows the FDA's decision in July 2024, making Palforzia the only oral immunotherapy approved for this age group in both regions. - Palforzia aims to desensitize patients by gradually increasing tolerance to peanuts, reducing the risk of severe allergic reactions from accidental exposure. - The approval is based on the Phase 3 POSEIDON study, which demonstrated Palforzia's efficacy and safety in young children with peanut allergies.
- The European Medicines Agency's CHMP has recommended Palforzia for treating peanut allergies in toddlers aged 1-3, marking a potential expansion of its use. - Palforzia, developed by Stallergenes Greer, aims to desensitize individuals to peanut allergens through controlled oral immunotherapy. - The recommendation is based on the Phase 3 POSEIDON trial, which demonstrated efficacy and a favorable safety profile in young children. - If approved by the European Commission, Palforzia would be the first EMA-approved oral immunotherapy for peanut allergies in this age group.
• Nestlé Health Science has sold its peanut allergy treatment Palforzia to Stallergenes Greer, just three years after acquiring Aimmune Therapeutics for $2.6 billion. • Despite being the first FDA-approved therapy for peanut allergy in children aged 4-17, Palforzia's market performance remained modest due to complex administration requirements and clinical monitoring challenges. • The acquisition positions Stallergenes Greer as the first company to offer both respiratory and food allergy treatments, while Nestlé retains future milestone payments and royalty rights.
