Italian family-controlled global pharmaceutical company established in 1935, headquartered in Parma; specializes in respiratory, neonatology and rare disease medicines, operating through 31 affiliates with products available in around 100 countries. Not publicly listed.
Clinical Trials
495
292 active
Approvals
82
Total approvals
Agencies
6
Regulatory bodies
Founded
1935
Active, not recruiting
288
58.2%
Approved For Marketing
1
0.2%
Available
1
0.2%
Completed
148
29.9%
Not yet recruiting
4
0.8%
Recruiting
34
6.9%
Terminated
15
3.0%
Withdrawn
4
0.8%
- Veld Pharmaceuticals GmbH and Chiesi Farmaceutici S.p.A have announced a collaboration to expand patient access to nine rare-disease therapies through a Managed Access Program across Africa. - The program enables physicians to prescribe therapies to patients with serious unmet medical needs who meet defined medical eligibility criteria and have appropriate funding mechanisms in place. - Veld will administer the program and facilitate access to Chiesi's rare-disease therapies on a named-patient basis, ensuring full compliance with local regulatory, ethical, and pharmacovigilance requirements. - The collaboration aims to ensure that patients with the highest unmet needs are no longer defined by geography while maintaining the highest standards of regulatory compliance and patient safety.
- The FDA has accepted Chiesi's New Drug Application for its investigational triple combination inhaler containing beclomethasone dipropionate, formoterol fumarate, and glycopyrrolate for maintenance treatment of asthma in adults. - The single inhaler triple therapy was the world's first fixed triple combination in a single inhaler and is already commercialized in nearly 50 countries outside the U.S., including the European Union, United Kingdom, and China. - Clinical data supporting the NDA comes from the TRIMARAN and TRIGGER Phase 3 trials, which evaluated safety and efficacy in more than 2,500 patients with uncontrolled asthma. - This regulatory milestone addresses a significant unmet need, as an estimated 60% of adults with asthma continue to experience frequent symptoms despite existing treatments, with asthma costing the U.S. an estimated $82 billion annually.
- Elgan Pharma and Chiesi Group have dosed the first patients in FIT-PIV, a Phase 3 trial evaluating ELGN-2112 for intestinal malabsorption in preterm infants. - The study will enroll 420 infants born at 26-32 weeks gestation across 50 sites in the UK, Europe, Israel and the United States. - ELGN-2112 is a proprietary recombinant human insulin formulation designed to improve gastrointestinal function and reduce complications in premature babies. - Previous trials showed infants treated with ELGN-2112 reached nutrition goals earlier and had shorter parenteral nutrition requirements with fewer complications.