Haleon Plc engages in the provision of personal healthcare products. The firm focuses on consumer healthcare. It operates under the following geographical segments: North America, EMEA and LatAm, and Asia Pacific. The company was founded on July 18, 2022 and is headquartered in Weybridge, the United Kingdom.
Clinical Trials
60
4 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2022
Active, not recruiting
1
1.7%
Completed
51
85.0%
Not yet recruiting
3
5.0%
Recruiting
5
8.3%
No approval data available
- India's Ministry of Health and Family Welfare has restricted the manufacture, sale, and distribution of fixed-dose combinations containing chlorpheniramine maleate and phenylephrine hydrochloride for children under four years of age. - The restriction, issued under Section 26A of the Drugs and Cosmetics Act, 1940, requires a prominent warning on labels, package inserts, and promotional materials stating the combination must not be used in children below four. - The decision follows recommendations from an Expert Committee and the Drugs Technical Advisory Board, which found safer alternatives exist and the combination may pose risks such as excessive drowsiness, agitation, and rapid heartbeat. - The Delhi High Court clarified the ban is not retrospective, allowing existing stock manufactured before the notification to continue being sold, reducing potential financial losses for manufacturers.
- A 2nd U.S. Circuit Court of Appeals panel revived portions of nationwide litigation alleging drugmakers sold billions of dollars in oral phenylephrine decongestants that were no better than placebo. - The court allowed claims over "maximum strength" labeling and brand-name drugs approved through the New Drug Application process to proceed, while preempting most state law-based claims. - An FDA advisory panel concluded in September 2023 that oral phenylephrine was ineffective as a decongestant, and the FDA proposed removing the ingredient from OTC cold medications in November 2024. - Circuit Judge Denny Chin acknowledged the apparent unfairness but stated the remedy "must flow not from litigation but from the FDA."
- Post-meal glucose moderation and soluble fiber dominate the post-meal fiber shots market, holding 39.0% and 42.0% shares respectively in 2026, driven by consumer awareness of meal-response behaviors. - Metabolic wellness users represent the leading consumer cohort across both categories, accounting for 36.0% (fiber shots) and 35.0% (glucose gummies) of market share, seeking non-prescription, pre-disease management solutions. - Claim compliance risk around glucose-related language is the primary restraint for both markets, with brands needing to avoid implying diabetes treatment or disease management to prevent retailer caution and platform review issues. - Amazon and DTC subscription channels are critical for trial and repeat purchasing, with Amazon holding 34.0% of glucose gummy discovery and DTC subscriptions capturing 32.0% of post-meal fiber shot repeat buying.
- The FDA has required updated labeling for Haleon's over-the-counter weight loss drug Alli to include warnings about potential acute kidney injury, a rare but potentially fatal side effect. - A safety review identified 12 cases of kidney complications linked to orlistat, prompting the agency to recommend that people with a history of kidney disease or kidney stones consult a doctor before use. - The labeling changes also instruct consumers to stop taking Alli and seek medical attention if they develop symptoms such as back or groin pain, painful urination, blood in urine, or reduced urination. - Alli, first approved in 2007, remains the only FDA-approved over-the-counter weight loss drug in the U.S., with an estimated 40 million people having taken orlistat since 1999.
- Haleon is voluntarily recalling four lots of Gas-X Extra Strength Softgels (125 mg, 120 ct. and 72 ct.) distributed on or after April 13, 2026, due to potential contamination with a diluted propylene glycol-based coolant from a machine leak during packaging. - Ingestion of contaminated softgels may result in adverse events such as nausea, vomiting, abdominal pain, and diarrhea, though no adverse event reports have been received to date. - The recall is being conducted with the knowledge of the U.S. FDA, and Haleon has identified and repaired the root cause while implementing corrective and preventive actions. - Consumers with affected lots should stop use immediately and contact Haleon for return and reimbursement; any related health issues should be reported to a healthcare provider and the FDA's MedWatch program.
- Singapore has unveiled a 350-square-meter Clinical Trial Centre at NUS Medicine dedicated to translating geroscience into clinical practice through precision geromedicine approaches. - The facility employs a multimodal approach combining biomarker-driven diagnostics, digital monitoring, and systems biology to tailor interventions based on individual biological age and health trajectories. - Current trials include PROMETHEUS combining exercise and lifestyle coaching, SIRT6 Activator exploring DNA-repair potential of fucoidan, and CEDIRA examining multivitamin effects on biological age. - The centre integrates research with education to train clinician-scientists while addressing the gap between biomarker discovery and real-world intervention in aging research.
- Emma Walmsley, the first woman to lead a major pharmaceutical company, will step down as GSK CEO on December 31 after more than eight years at the helm. - Luke Miels, currently GSK's chief commercial officer, will take over as CEO on January 1, 2025, amid investor concerns about the company's growth trajectory. - Despite strategic successes including the Haleon spinoff, GSK's shares fell 11% during Walmsley's tenure, with growth rates remaining in single-digit territory. - GSK faces challenges including patent losses on its HIV franchise and vaccine business difficulties, while rival companies have outpaced its performance.
- Haleon and Brightseed have formed a strategic collaboration to utilize Brightseed's Forager® AI platform for discovering plant-based small molecules with potential health benefits. - The partnership will give Haleon's scientists direct access to the Forager platform, integrating AI-powered discovery into their research and product development pipelines. - Brightseed's technology has already identified plant compounds with applications in metabolic health, gut health, and immunity, aligning with Haleon's commitment to science-backed consumer health innovation.
- Pfizer has sold its remaining 7.3% stake in consumer healthcare company Haleon for $3.3 billion through a secondary offering and share repurchase agreement, marking its complete exit from the UK-based firm. - The sale comes two years after Haleon was spun off as an independent public company in July 2022, following the 2019 merger of GlaxoSmithKline's and Pfizer's consumer healthcare divisions. - Following Pfizer's exit, BlackRock Investment Management (UK) Ltd. will become Haleon's largest shareholder with more than a 5% stake, while Haleon will repurchase £170 million worth of its shares as part of the transaction.
• The FDA has approved Johnson & Johnson's Tremfya for moderately to severely active Crohn's disease, marking its fourth indication in the US based on robust data from phase III GALAXI and GRAVITI studies. • Novartis received FDA approval for Fabhalta to treat C3 glomerulopathy, becoming the first and only drug approved to address the underlying cause of this ultra-rare progressive kidney disease. • AstraZeneca announced plans to acquire Belgium-based EsoBiotec for up to $1 billion, while Sanofi is purchasing Dren Bio's DR-0201 for $600 million upfront to strengthen its immunology pipeline.
