GSK plc
British multinational pharmaceutical and biotechnology company, formed in 2000 through the merger of Glaxo Wellcome and SmithKline Beecham; manufactures pharmaceuticals, vaccines, and consumer healthcare products across asthma, cancer, infections, diabetes, and mental health.
Clinical Trials
3905
202 active
Approvals
131
Total approvals
Agencies
1
Regulatory bodies
Founded
2000
Not yet recruiting
41
1.1%
No Longer Available
5
0.1%
Terminated
241
6.2%
Recruiting
92
2.4%
Suspended
2
0.1%
Available
3
0.1%
Withdrawn
116
3.0%
Active, not recruiting
161
4.1%
Unknown
7
0.2%
Completed
3237
82.9%
- European Commission and EMA officials outlined pending EU pharmaceutical legislation that would replace two decades of rules with a new Directive and Regulation. - The reforms would cut the EMA from six committees to two and reduce scientific assessment time from 210 days to 180 days. - An antimicrobial voucher granting an extra year of data protection aims to incentivize developers targeting multi-drug-resistant organisms. - EFPIA's representative flagged industry concerns over insufficient advance notice for guidances and called for feasible implementation timelines.
- GSK has secured full global rights to Chimagen Biosciences' unnamed trispecific T-cell engager for multiple myeloma in a deal worth up to $750 million. - The preclinical asset is designed to bind T cells while targeting two tumor-associated antigens, aiming for deeper responses and better tolerability than existing engagers. - GSK plans to begin Phase 1 testing in 2027, adding to a myeloma portfolio anchored by the BCMA-directed antibody-drug conjugate Blenrep. - The deal is GSK's second with Chimagen, following the 2024 licensing of the CD19/CD20-targeted T-cell engager CMG1A46 for B-cell malignancies and autoimmune disease.
- In the Phase I/II ARROS-1 trial, zidesamtinib produced a 94% objective response rate in 94 TKI-naive patients with advanced ROS1-positive NSCLC by blinded independent central review. - Among 10 evaluable patients with CNS metastases, intracranial objective response rate reached 100%, including a 70% intracranial complete response rate. - GSK plans a supplemental new drug application to the FDA later this year seeking first-line approval, after Jideytro's July approval in previously treated disease. - Treatment-related adverse events led to dose reductions in 11% and discontinuation in 1%, with peripheral edema the most common event at 34%.
- Mepolizumab (Nucala) is now PBS-listed for adults with uncontrolled COPD and raised blood eosinophils, as an add-on to optimised inhaler triple therapy. - An estimated 496,000 Australians aged 45 and over were living with COPD in 2022, and studies suggest 20-35% have high blood eosinophils. - Mepolizumab is a monoclonal antibody that blocks interleukin-5, reducing eosinophil numbers and COPD flare-ups; serious side effects occurred in 1% of trial patients.
- The Phase III ARTEMIS-008 trial showed risvutatug rezetecan reduced the risk of death by 54% versus topotecan in relapsed small-cell lung cancer. - Median overall survival reached 18.5 months with Ris-Rez versus 10.3 months with topotecan after a median follow-up of 12.2 months. - Grade 3 or higher treatment-related adverse events occurred in 60.9% of Ris-Rez patients versus 78.2% with topotecan, mostly hematologic toxicities. - GSK, which holds ex-China rights to the B7-H3-directed antibody-drug conjugate, is advancing a global development program including the Phase III EMBOLD SCLC-301 trial.
- GSK and Hansoh reported that the B7-H3-targeted antibody-drug conjugate risvutatug rezetecan reduced the risk of death by 54% versus topotecan in relapsed small cell lung cancer. - In the phase III ARTEMIS-008 trial, median overall survival reached 18.5 months with Ris-Rez versus 10.3 months with topotecan after a median 12.2 months of follow-up. - Secondary endpoints favored Ris-Rez, with median progression-free survival of 7.2 versus 3.0 months and objective response rates of 58.3% versus 12.6%. - Grade 3 or higher treatment-related adverse events occurred in 60.9% of Ris-Rez patients versus 78.2% with topotecan, with hematologic toxicities predominating.
- Yuhan registered a U.S. patent on July 21 covering bicyclic fused ring derivatives that inhibit the LOX enzyme family, a preclinical small-molecule anti-fibrosis candidate. - The patent lists idiopathic pulmonary fibrosis, MASH, chronic kidney disease and liver cirrhosis as target indications, positioning the asset across multiple organ fibrosis markets. - The LOX inhibitor differs mechanistically from Yuhan's disclosed MASH candidate YH25724, which acts on FGF21 and GLP-1 and entered domestic Phase 1 planning in May. - Industry analysts see potential licensing value as global fibrosis and MASH dealmaking accelerates, though Yuhan cautions the candidate remains preclinical and success is unproven.
- NICE has issued draft guidance declining NHS commissioning of lenacapavir, the twice-yearly injectable HIV prevention drug already approved by the MHRA and prescribed privately. - The draft rests on absent head-to-head data versus GSK's two-monthly injectables, mismatched trial populations, and a price above NICE's cost effectiveness threshold. - Charities including Terrence Higgins Trust and HIV i-Base note the clinical case is uncontested, and a November NICE meeting leaves room for a confidential discount.
- The FDA approved Moderna's mFLUSIVA in August 2026, making it the first seasonal influenza vaccine in the US to use mRNA-based production. - In a phase 3 trial of more than 40,000 adults aged 50 and older, 2% of mFLUSIVA recipients developed flu illness versus 2.8% on a standard-dose vaccine. - mFLUSIVA encodes full-length hemagglutinin from three WHO-recommended influenza strains delivered by lipid nanoparticles, and the 2026-27 formula contains no egg protein. - About 75% of mFLUSIVA recipients reported at least one expected short-term reaction compared with 47% of standard-dose vaccine recipients, with most reactions mild or moderate.
- Alteogen signed an exclusive option and license agreement with Novartis for its hyaluronidase ALT-B4, with maximum payments reaching $3.223 billion if all options and milestones are achieved. - Novartis secured multiple options to develop and commercialize subcutaneous formulations of biopharmaceuticals using ALT-B4, choosing it over Halozyme's Enhanze platform. - ALT-B4's patent protection extends into the early 2040s, while Halozyme's core composition-of-matter patents expire between 2027 and 2029, reinforcing Alteogen's long-term exclusivity position.
