Clinical Trials
15
9 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Active, not recruiting
7
46.7%
Completed
6
40.0%
Not yet recruiting
2
13.3%
No approval data available
- Japan's Ministry of Health, Labour and Welfare granted orphan drug designation to opamtistomig (LBL-024) for extrapulmonary neuroendocrine carcinoma, the antibody's third such designation globally. - The designation follows orphan status from the U.S. FDA and European Commission, plus FDA Fast Track and China NMPA Breakthrough Therapy Designation for the PD-L1/4-1BB bispecific. - Opamtistomig is being evaluated in 14 indications, including one pivotal single-arm registrational study, one confirmatory Phase III trial and nine proof-of-concept studies. - A New Drug Application accepted by China's NMPA in August 2026 positions opamtistomig as a potential first approved 4-1BB-targeting antibody and first approved EP-NEC treatment.
- Shionogi received European Commission marketing authorization for Zokovea (ensitrelvir) for post-exposure prophylaxis of COVID-19 in adults and adolescents aged 12 years and older. - The approval makes Zokovea the first oral antiviral authorized in the EU for COVID-19 post-exposure prophylaxis, based on the Phase 3 SCORPIO-PEP trial. - In SCORPIO-PEP, ensitrelvir cut the risk of symptomatic COVID-19 through Day 10 by 67% versus placebo, with adverse event rates of 15.1% and 15.5%. - Ensitrelvir is marketed as Xocova in Japan and the United States, where it is also approved for COVID-19 treatment and post-exposure prophylaxis.
- Alzinomics said the EMA's Committee for Orphan Medicinal Products recommended Orphan Drug Designation for its RNA editing-based gene therapy RZ-001 in glioma. - COMP cited significant benefit over existing European treatments, weighing increased response rates and continuous tumor regression seen on imaging in recurrent glioblastoma patients. - RZ-001 is in phase 1/2a trials in Korea and the US, with 10 patients dosed and 3 more treated under FDA Expanded Access.
- The EMA's Committee for Orphan Medicinal Products adopted a positive opinion on September 28 recommending orphan drug designation for Rznomics' RZ-001 in glioma. - The committee judged RZ-001 capable of delivering significant benefit despite existing approved therapies, citing clinical responses in recurrent glioblastoma patients. - RZ-001 is an adenovirus type 5-based gene therapy carrying an RNA replacement enzyme targeting hTERT mRNA plus an HSV-TK gene. - Thirteen patients with hTERT-positive recurrent glioblastoma have been treated across Phase 1/2a trials in South Korea and the US and an FDA expanded access program.
- The European Commission revoked the EU marketing authorization for Hansoh Pharmaceutical's aumolertinib after finding its 2022 application improperly referenced protected osimertinib clinical data. - Hansoh said the decision is procedural and unrelated to aumolertinib's quality, safety, efficacy or clinical value, and plans to resubmit to the EMA. - The revocation followed AstraZeneca's General Court challenge to the original authorization, and the EC acted without waiting for that litigation to conclude. - Aumolertinib's UK authorization from June 2025 remains valid, and Hansoh reported no ex-China sales revenue for the drug as of the announcement.
- The European Commission granted marketing authorisation under exceptional circumstances for NEZGLYAL (leriglitazone) on 21 September 2026, making it the first approved pharmacological treatment for cALD in the EU. - The oral, brain-penetrant selective PPAR gamma agonist is indicated for male cALD patients aged 2 to 12 years with Gd-negative brain lesions and a Neurological Functional Score of 0 or 1. - Approval rests on the Phase 2/3 NEXUS study plus real-world compassionate use evidence, with NEXUS showing paediatric patients clinically and radiologically stable beyond 96 weeks of treatment. - Neuraxpharm expects a first European launch in Germany by the end of the year, while Minoryx continues the CALYX Phase 3 and TREE Phase 2a trials in adult cALD and Rett syndrome.
- Biocon received MHRA approval for a new drug product fill-finish unit for Semglee (insulin glargine) at its insulin manufacturing facility in Malaysia. - The UK clearance, announced on September 25, 2026, follows EMA approval of the same fill-finish line in July 2026, a two-month regulatory sequence. - The approval validates the Malaysian plant's operational readiness for commercial production and expands Biocon's supply chain capacity for diabetes care products. - Biocon also holds a CHMP positive opinion for its pertuzumab biosimilar Pebrilzo, the first monoclonal antibody biosimilar reviewed under the EMA's tailored clinical development approach.
- The FDA has granted priority review to the registration application for satralizumab (Enspryng) in MOGAD, an autoimmune disease attacking the myelin sheath of nerve fibres. - The filing rests on Phase III data showing a 68% reduction in relapse risk versus placebo, with 87% of treated patients relapse-free at 48 weeks. - The EMA has validated the European marketing authorisation application for the same indication, with an FDA decision expected by 10 January 2027.
- The EU General Court dismissed Advanz Pharma's challenge to the European Commission's 2024 decision revoking the conditional marketing authorisation for Ocaliva in primary biliary cholangitis. - The court held that a pending renewal application does not bar the Commission from completing a separate review where public-health grounds justify withdrawing a medicine. - Judges found no manifest error in CHMP's conclusion that the confirmatory trial 747-302 failed to establish clinical benefit, and rejected conflict-of-interest claims.
- The European Commission approved Trixeo Aerosphere as maintenance treatment for asthma in patients 12 years and older uncontrolled on medium-dose ICS/LABA therapy. - Trixeo becomes the first and only triple-combination therapy approved in the EU for asthma regardless of patients' prior exacerbation history. - Approval rests on the Phase III KALOS and LOGOS trials, which showed significant lung function gains and fewer severe exacerbations versus ICS/LABA comparators. - The fixed-dose inhaler combines budesonide, glycopyrronium and formoterol fumarate, and is marketed as Breztri Aerosphere in the US, China and Japan.
