相关临床试验
38
5 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
进行中（未招募）
4
10.5%
已完成
30
79.0%
尚未招募
1
2.6%
终止
3
7.9%
暂无批准数据
- The FDA issued a complete response letter for cytisinicline, declining approval solely due to third-party manufacturing facility issues and incomplete product labeling, with no clinical efficacy or safety deficiencies identified. - Achieve's late-stage trials involving over 1,500 participants demonstrated that cytisinicline helped more adults quit smoking than placebo, with benefits lasting through 24 weeks and no new safety concerns. - The company has moved manufacturing to U.S.-based Adare Pharma Solutions and plans to resubmit its application in Q4 2026, with potential FDA approval in the first half of 2027. - Analysts view the absence of clinical deficiencies as a key positive, noting cytisinicline's potential to reactivate the large, underdeveloped smoking cessation market.
- Achieve Life Sciences announced a $354 million private placement led by major healthcare investors to advance cytisinicline development for nicotine dependence treatment. - The funding includes $180 million upfront with an additional $174 million available through warrants exercisable within 20 days of FDA approval for smoking cessation. - Proceeds will fund a Phase 3 clinical trial for cytisinicline in e-cigarette cessation and commercialization efforts, with FDA review ongoing under a June 2026 PDUFA date. - The company appointed Dr. Andrew Goldberg as new CEO while awaiting FDA decision on cytisinicline for smoking cessation based on completed Phase 3 studies.
- Achieve Life Sciences has partnered with U.S.-based Adare Pharma Solutions to manufacture cytisinicline, reducing supply chain risks and potential costs ahead of the anticipated FDA approval decision on June 20, 2026. - The FDA has accepted cytisinicline's New Drug Application for smoking cessation treatment, with the drug receiving Commissioner's National Priority Voucher status for e-cigarette cessation as one of the first nine therapies selected. - Recent clinical data published in JAMA Internal Medicine and Thorax demonstrate cytisinicline's efficacy across diverse patient populations, including those with COPD and patients with multiple prior quit attempts. - The company reported $36.4 million in cash reserves as of December 31, 2025, with plans for commercial launch in the first half of 2027 if approved.
- A pooled Phase 3 analysis of over 1,600 participants demonstrated that cytisinicline achieved high quit rates regardless of participants' prior use of smoking cessation medications or number of previous quit attempts. - The analysis combined data from ORCA-2 and ORCA-3 trials, showing efficacy across participants with varying histories of prior quit medications including varenicline, bupropion, and nicotine replacement therapy. - Late-breaking survey data from the year-long ORCA-OL safety study revealed positive participant experiences with extended cytisinicline use, including successful quitting and improvements in physical health. - Achieve Life Sciences' New Drug Application for cytisinicline has been accepted by the FDA for review, with a PDUFA date of June 20, 2026.
- Achieve Life Sciences has named Dr. Mark Rubinstein as Interim Chief Medical Officer, succeeding Dr. Cindy Jacobs as the company advances its smoking cessation drug cytisinicline. - The FDA recently accepted the company's New Drug Application for cytisinicline with a PDUFA completion date of June 20, 2026, targeting the estimated 15 million American adults who attempt to quit smoking annually. - Cytisinicline has received FDA Breakthrough Therapy designation for e-cigarette cessation, addressing an unmet medical need with no currently approved treatments for vaping cessation. - The plant-derived alkaloid works by binding to nicotinic acetylcholine receptors to reduce nicotine cravings and the rewarding effects of tobacco products.
- Achieve Life Sciences has filed for FDA approval of cytisinicline, which would be the first new smoking cessation medication in nearly 20 years if approved. - Phase 3 trials demonstrated a 20.5% effectiveness rate for cytisinicline compared to 5% for placebo, with fewer side effects than existing treatments like varenicline. - FDA approval is expected by mid-2026 with U.S. market launch by the end of that year, targeting the 29 million Americans who currently smoke cigarettes. - The drug addresses a significant unmet need as less than 1% of smokers succeed in quitting annually despite 67.7% expressing desire to quit.
- Achieve Life Sciences' ORCA-OL trial met the FDA's requirement of at least 300 participants completing six months of cytisinicline treatment, a key milestone for NDA submission. - The Data Safety Monitoring Committee found no safety concerns, allowing the ORCA-OL trial to proceed without modifications, reinforcing cytisinicline's safety profile. - Achieve Life Sciences remains on track to submit its New Drug Application for cytisinicline in Q2 2025, potentially offering a novel treatment for nicotine dependence. - Cytisinicline has Breakthrough Therapy designation for vaping cessation, addressing a critical need with no FDA-approved treatments currently available.
- Achieve Life Sciences received FDA agreement on its Phase 3 trial design for cytisinicline as a vaping cessation treatment. - The FDA indicated that one Phase 3 trial (ORCA-V2), along with the Phase 2 ORCA-V1 trial, is sufficient for approval. - The ORCA-V2 trial will evaluate 3 mg of cytisinicline three times daily versus placebo in approximately 800 adult e-cigarette users. - With 60% of 11 million U.S. adult vapers wanting to quit, cytisinicline addresses a significant unmet need.
- Achieve Life Sciences is developing cytisinicline, a novel treatment for vaping addiction, which has received "breakthrough therapy" designation from the FDA. - Zacks Small-Cap Research has set a price target of $30 per share for Achieve, citing significant developments in the company's business and clinical trials. - The FDA has requested additional safety data on long-term cytisinicline use, potentially delaying regulatory approval until the third quarter of 2026. - Cytisinicline, derived from plants, is undergoing testing in adults, with potential expansion to adolescents in 2025 pending FDA approval.
- Achieve Life Sciences completed enrollment in its Phase 3 ORCA-OL trial, evaluating cytisinicline for smoking and vaping cessation, with 479 participants across 29 U.S. sites. - The FDA granted Breakthrough Therapy designation to cytisinicline for nicotine e-cigarette cessation, expediting its development and review. - Achieve remains on track for planned NDA submission in the second quarter of 2025, driven by the potential to address the urgent need for effective smoking and vaping cessation solutions. - Recent leadership appointments at Achieve underscore a commitment to strategic growth and maximizing shareholder value.
