Clinical Trials
80
5 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Active, not recruiting
4
5.0%
Completed
75
93.8%
Not yet recruiting
1
1.3%
No approval data available
- Shionogi and Torii Pharmaceutical obtained Japanese manufacturing and marketing approval for VTAMA Cream 0.5% (tapinarof) for atopic dermatitis in pediatric patients under 12 years of age. - The approval was based on a domestic Phase 3 trial in children aged 2 to under 12 in which the drug met its primary efficacy endpoint versus vehicle cream. - Pooled Phase 3 ADORING data showed consistent vIGA-AD and EASI75 improvements across pediatric age groups, with responses observed as early as week 2. - Tapinarof is a first-in-class nonsteroidal topical aryl hydrocarbon receptor agonist, offering a steroid-free option for a disease that frequently develops in childhood.
- Shionogi has completed the succession of Japan Tobacco Inc.'s pharmaceutical business and acquisition of Akros Pharma Inc. shares through a simplified absorption-type company split. - The Japanese pharmaceutical company announced plans to merge with its wholly owned manufacturing subsidiary Shionogi Pharma Co., Ltd., effective April 1, 2027. - The merger aims to strengthen functional collaborations and build a robust production and supply system to adapt to environmental changes in the pharmaceutical supply chain. - Shionogi is accelerating globalization and business expansion primarily focused on in-house discovered infectious disease products under its SHIONOGI Transformation Strategy 2030 Revision.
- LEO Pharma has initiated the DELTA NEXT phase 2a trial to evaluate delgocitinib cream versus placebo in adults with mild to severe palmoplantar pustulosis, a rare inflammatory skin condition. - The study will recruit up to 135 patients across 40-45 sites in the US, Canada, UK, Germany, and Poland, targeting patients for whom topical corticosteroids are inadequate or inadvisable. - Palmoplantar pustulosis currently has no approved advanced systemic treatments in the US or Europe, representing a significant unmet medical need for patients experiencing pain, fatigue, and impaired quality of life. - Delgocitinib cream is a topical pan-JAK inhibitor already approved in Europe for chronic hand eczema, offering potential therapeutic benefit through inhibition of multiple inflammatory pathways.
- Shionogi & Co. plans to acquire Japan Tobacco's pharmaceutical subsidiaries Torii Pharmaceutical and Akros Pharma for ¥160 billion ($1.1 billion) to strengthen its global R&D capabilities. - The acquisition, negotiated since early 2024, will proceed through a tender offer beginning June 18 with a share price of ¥6,350 to acquire at least 11.89% of the minority stake. - This strategic move represents significant consolidation in the Japanese pharmaceutical sector and expands Shionogi's market presence amid increasing global competition.
- Shionogi received a "Notice of Non-issuance of Cease and Desist Order" from Japan's Fair Trade Commission on May 28, 2025, clearing regulatory hurdles for its tender offer to acquire Torii Pharmaceutical. - The company is conducting a tender offer at 6,350 yen per share to make Torii Pharmaceutical a wholly-owned subsidiary, with Japan Tobacco holding 54.78% of shares agreeing not to tender in the offer. - The acquisition aims to create synergies in domestic pharmaceutical sales, accelerate global development capabilities, and establish flexible manufacturing structures through integration of both companies' complementary strengths.
- The phase 3 DELTA FORCE trial demonstrated superior efficacy of topical delgocitinib cream over oral alitretinoin capsules for severe chronic hand eczema, with results published in The Lancet. - Delgocitinib cream, a pan-JAK inhibitor, achieved all primary and secondary endpoints with fewer treatment-emergent adverse events compared to alitretinoin, the only currently approved treatment for severe CHE in Canada. - The investigational topical treatment is already approved in Europe, UK, Switzerland, and UAE, while remaining under regulatory review in Canada and the United States.
- D-Wave Quantum Inc. and Japan Tobacco have successfully completed a proof-of-concept project that combines quantum computing with AI to accelerate drug discovery, outperforming classical computing methods. - The quantum-hybrid workflow enhanced large language models to generate more valid and "drug-like" molecular structures than traditional methods, potentially revolutionizing the identification of first-in-class small molecule compounds. - This breakthrough represents the first documented case where annealing quantum computation outperformed classical results in LLM training for pharmaceutical development, according to Japan Tobacco's Chief Scientific Officer.
- The European Medicines Agency's CHMP has issued a positive opinion for XOANACYL, an oral therapy for chronic kidney disease, with final European Commission approval expected by June 2025. - XOANACYL offers a dual mechanism of action, providing ferric iron for addressing iron deficiency while controlling phosphorus absorption in CKD patients, addressing two common complications of the disease. - Averoa, which licensed XOANACYL from Akebia Therapeutics in 2022, is actively seeking strategic commercial partnerships to bring the treatment to market across Europe following anticipated regulatory approval.
