News about "Phase 3 clinical trial"

Suven Completes Phase 3 Enrollment of Masupirdine for Alzheimer's-Related Agitation

Suven Life Sciences completes enrollment in its global Phase 3 masupirdine trial, with 424 patients randomised to evaluate the therapy for agitation associated with Alzheimer’s dementia.

Phase 3 Clinical Trial | 05/09/2026 | By News Bureau

Pharming Launches Joenja in Japan for APDS Patients Aged 4 and Older

Pharming has launched Joenja in Japan for APDS patients aged 4 years and older, making Japan the first market to offer the treatment commercially to children aged 4–11.

Phase 3 Clinical Trial | 14/08/2026 | By News Bureau |  113

Sobi and Innate Pharma Partner to Advance Lacutamab in T-Cell Lymphoma

Sobi and Innate Pharma partners to advance lacutamab into the TELLOMAK-3 Phase 3 trial, supporting its potential accelerated approval in Sézary syndrome and future development across cutaneous T-cell lymphoma.

Phase 3 Clinical Trial | 10/08/2026 | By News Bureau |  101

Gilead and Merck Report Positive Phase 3 Results for Investigational Once-Weekly Oral HIV Therapy

ISLEND-1 and ISLEND-2 trials demonstrate non-inferior efficacy and favourable safety profile, supporting regulatory submissions for what could become the first once-weekly oral HIV treatment.

Phase 3 Clinical Trial | 22/07/2026 | By News Bureau

Opus Genetics Aligns with US FDA on Phase 3 OPGx-LCA5 Trial

Opus Genetics has aligned with the US Food and Drug Administration (FDA) on the Phase 3 trial design for OPGx-LCA5 in inherited retinal disease, with phase 3 dosing expected in Q4 2026 and a potential Biologics License Application (BLA) submission based on 6-month efficacy data.

Phase 3 Clinical Trial | 07/07/2026 | By News Bureau |  175

Glenmark Advances Global Phase 3 Trial of HER2-Targeted ADC for Platinum-Resistant Ovarian Cancer

Glenmark Specialty has initiated patient enrolment in India for the Phase 3 trial of trastuzumab rezetecan, aiming to expand treatment options for patients with platinum-resistant ovarian cancer across its licensed global markets.

Phase 3 Clinical Trial | 04/07/2026 | By News Bureau |  150

Newron Provides Update Following Type A Meeting with the US FDA

Newron has provided an update following its Type A meeting with the US Food and Drug Administration (FDA), outlining the steps required to resume US enrollment in the phase 3 ENIGMA-TRS 2 schizophrenia study.

Phase 3 Clinical Trial | 04/07/2026 | By News Bureau |  190

Roche's Divarasib Outperforms KRAS G12C Inhibitors in Phase 3 NSCLC Trial

Roche’s divarasib demonstrated superior Progression-Free Survival over approved KRAS G12C inhibitors in the phase 3 Krascendo-1 trial for previously treated advanced Non-Small Cell Lung Cancer (NSCLC).

Phase 3 Clinical Trial | 02/07/2026 | By News Bureau |  131

Merck's Tulisokibart Met Primary and Key Secondary Endpoints in Phase 3 ATLAS-UC Induction

Merck’s tulisokibart achieved both primary and key secondary endpoints in the phase 3 ATLAS-UC induction study, demonstrating significant efficacy in patients with moderately to severely active Ulcerative Colitis (UC).

Phase 3 Clinical Trial | 23/06/2026 | By News Bureau |  427

US FDA Approves Utebzi for Adult Patients with Complicated UTIs

The US Food and Drug Administration (FDA) has approved GSK’s Utebzi (tebipenem pivoxil) for adults with complicated Urinary Tract Infections (cUTIs), becoming the first and only oral carbapenem antibiotic available. The approval is based on the phase 3 PIVOT-PO trial, which demonstrated non-inferiority to standard intravenous antibiotic treatment.

Phase 3 Clinical Trial | 19/06/2026 | By News Bureau |  159