TAK-861

Takeda's Oveporexton Shows Promising Results in Phase 2b Trial for Narcolepsy Type 1

8 days ago

• The New England Journal of Medicine published data showing Takeda's investigational oral orexin receptor 2 agonist oveporexton demonstrated significant improvements in wakefulness and reduced cataplexy events in narcolepsy type 1 patients. • All tested doses of oveporexton helped patients achieve near-normal ranges of wakefulness while addressing the underlying orexin deficiency that causes narcolepsy type 1, with improvements sustained over the 8-week trial period. • The drug was generally well-tolerated with mostly mild to moderate side effects, and 95% of participants enrolled in the long-term extension study, with Phase 3 trial results anticipated later in 2025.

Hypersomnia Pipeline Shows Promise with 10+ Emerging Therapies in Development

2 months ago

• DelveInsight's latest report reveals 8+ companies developing 10+ therapies for hypersomnia, with Avadel's Lumryz, Zevra's KP1077, and Alkermes' ALKS 2680 among the key candidates advancing through clinical trials. • Recent clinical milestones include Axsome's AXS-12 meeting its Phase III primary endpoint with 72-82% reduction in cataplexy attacks, and Takeda's TAK-861 showing promise as the first treatment targeting the underlying pathophysiology of narcolepsy type 1. • The hypersomnia market is driven by increased awareness, unmet medical needs, and advances in neuroscience, though challenges remain including lack of biomarkers, high trial costs, and regulatory hurdles.

FDA Approves Zepbound as First Drug for Obstructive Sleep Apnea in Obese Adults

5 months ago

• The FDA has approved Zepbound (tirzepatide) as the first medication for treating moderate-to-severe obstructive sleep apnea (OSA) in obese adults. • Clinical trials showed Zepbound significantly reduced breathing disruptions and promoted weight loss compared to placebo, with nearly half of patients experiencing remission of OSA symptoms. • The drug is intended for use alongside a reduced-calorie diet and increased physical activity, offering a new approach to managing OSA and obesity. • While Zepbound shows promise, it's not suitable for all OSA patients, and continued weight loss is required for sustained effectiveness; common side effects include gastrointestinal issues.

Takeda Highlights Late-Stage Pipeline with Potential Blockbuster Drugs

5 months ago

• Takeda is advancing six late-stage programs with a potential peak revenue of $10B-$20B, aiming for sustainable growth through innovative therapies. • Phase 3 data readouts are expected in 2025 for oveporexton (TAK-861) in narcolepsy, zasocitinib (TAK-279) in psoriasis, and rusfertide (TAK-121) in polycythemia vera. • Regulatory filings for oveporexton, zasocitinib, and rusfertide are on track for fiscal years 2025-2026, with additional filings anticipated through 2029. • Key programs include mezagitamab (TAK-079) for immune thrombocytopenia, fazirsiran (TAK-999) for alpha-1 antitrypsin deficiency, and elritercept (TAK-226) for anemia in myelodysplastic syndromes.

Takeda's Growth & Launch Portfolio Drives H1 2024 Revenue Increase; Full-Year Guidance Revised

7 months ago

• Takeda reported a 5% revenue increase in H1 2024, driven by an 18.7% growth in its Growth & Launch product portfolio, offsetting declines in VYVANSE sales. • The company raised its full-year guidance due to strong H1 performance and updated foreign exchange assumptions, while core operating profit margin reached 30.2%. • Takeda is actively investing in late-stage pipeline programs, including Phase 3 trials for TAK-861 (narcolepsy) and mezagitamab (IgA nephropathy). • Despite robust performance, Takeda anticipates challenges in H2 due to accelerated generic erosion of VYVANSE and increased R&D spending.

Takeda's Growth Products Drive Strong First Half, Phase 3 Trial of TAK-861 Initiated

7 months ago

• Takeda reports a 13.4% revenue increase in the first half of FY2024, driven by Growth & Launch Products, including ENTYVIO, and geographical expansion with ADZYNMA and FRUZAQLA. • The company has initiated a Phase 3 trial for TAK-861 in narcolepsy type 1, showcasing advancements in its late-stage pipeline and commitment to developing life-transforming treatments. • Takeda upgrades its full-year forecasts, reflecting stronger-than-anticipated performance and revised foreign exchange assumptions, while planning to increase R&D investment in the second half. • Management Guidance for FY2024 has been upgraded, with Core Revenue expected to be flat to slightly increasing and Core Operating Profit decline in the mid-single-digit percentages.

Takeda's TAK-861 Shows Promise in Phase IIb Trial for Narcolepsy Type 1

7 months ago

• Takeda's TAK-861, an orexin receptor-2 agonist, demonstrates potential transformational efficacy in Phase IIb trials for narcolepsy type 1 (NT1). • The drug aims to restore missing orexin, addressing symptoms like excessive daytime sleepiness and cataplexy, offering a comprehensive treatment approach. • Takeda is using at-home wearable devices to enhance diagnosis and monitoring of sleep-wake disorders, improving patient access and data collection. • Phase III trials are underway to confirm the promising Phase II data, with hopes of transforming NT1 treatment and expanding applications to other sleep disorders.

Takeda Presents New Data on TAK-861 Orexin Agonist for Narcolepsy at Sleep Europe 2024

8 months ago

• Takeda presented Phase 2b trial data of TAK-861, an oral orexin receptor 2 selective-agonist, demonstrating improvements in daily functioning, cognition, and sleep quality in narcolepsy type 1 (NT1). • An interim analysis of a long-term extension study of TAK-861 showed sustained efficacy and safety, with some patients reaching one year of treatment. • Based on positive Phase 2b results, Takeda has initiated a global Phase 3 trial (FirstLight Study) to further evaluate the efficacy and safety of TAK-861 in adults with NT1. • Takeda is also progressing TAK-360, another orexin agonist, for narcolepsy type 2 and idiopathic hypersomnia, highlighting its commitment to addressing various sleep-wake disorders.

Takeda's TAK-861 Shows Promising Results in Phase 2b Trial for Narcolepsy Type 1

a year ago

• Takeda's investigational oral orexin receptor 2 agonist TAK-861 demonstrated statistically significant improvements across all primary and secondary endpoints in a Phase 2b trial for narcolepsy type 1. • The 8-week study involving 112 patients showed sustained efficacy in reducing excessive daytime sleepiness and cataplexy frequency, with most participants achieving normative ranges for key measures. • Based on these promising results, Takeda plans to initiate global Phase 3 trials in the first half of 2024, supported by the FDA's Breakthrough Therapy designation for TAK-861.

Drug Development Updates