This section highlights FDA-related milestones and regulatory updates for drugs developed by Achieve Life Sciences (ACHV).
Over the past two years, Achieve Life Sciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ORCA-OL, cytisinicline, Cytisinicline, and Cytisinicline. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
ORCA-OL FDA Regulatory Timeline and Events
ORCA-OL is a drug developed by Achieve Life Sciences for the following indication: For smoking cessation and nicotine dependence.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ORCA-OL
- Announced Date:
- March 4, 2026
- Indication:
- For smoking cessation and nicotine dependence,
Announcement
Achieve Life Sciences, Inc announced new data showing that 6 and 12 weeks of cytisinicline delivers meaningful quitting success, regardless of participants' prior use of smoking cessation medications or number of previous quit attempts.
AI Summary
Achieve Life Sciences announced a pooled Phase 3 analysis of more than 1,600 people who smoke showing that both 6- and 12-week courses of cytisinicline produced meaningful quitting success. Quit rates were high even among participants who had previously tried other smoking cessation medications without success, and outcomes did not depend on the number of prior quit attempts. The company said the findings suggest cytisinicline can help a broad group of people who want to stop smoking.
Achieve also reported late-breaking survey data from the year-long ORCA-OL safety study highlighting participant experience with extended cytisinicline use. These safety and experience results will be presented at the Society for Research on Nicotine & Tobacco (SRNT) 2026 Annual Meeting, March 4–7 in Baltimore. Achieve said the data reinforce cytisinicline’s potential as an accessible option to support quitting across diverse smokers.
Read Announcement- Drug:
- ORCA-OL
- Announced Date:
- February 10, 2025
- Target Action Date:
- Q2 2025
- Estimated Target Date Range:
- April 1, 2025 - June 30, 2025
- Indication:
- For smoking cessation and nicotine dependence,
Announcement
Achieve Life Sciences, Inc announced that Achieve Reiterates Planned Cytisinicline NDA Submission in Q2 2025
AI Summary
Achieve Life Sciences, Inc. has reaffirmed its plan to submit a New Drug Application (NDA) for cytisinicline in the second quarter of 2025. This decision follows the Data Safety Monitoring Committee’s second independent review of the ongoing ORCA-OL trial, which is assessing the long-term exposure of the 3 mg cytisinicline treatment for individuals looking to quit smoking or vaping. The review reported no unexpected treatment-related adverse events, and participants showed excellent adherence to the medication.
The positive safety profile observed in the ORCA-OL trial supports the company’s confidence in cytisinicline as a promising new treatment option for nicotine dependence. This planned NDA submission is a key milestone for Achieve Life Sciences as it prepares to offer physicians and patients an important new tool for smoking cessation.
Read Announcement- Drug:
- ORCA-OL
- Announced Date:
- February 10, 2025
- Indication:
- For smoking cessation and nicotine dependence,
Announcement
Achieve Life Sciences, Inc. announced that the Data Safety Monitoring Committee (DSMC) has recently completed its second independent review of the ongoing ORCA-OL trial, evaluating long-term exposure of the novel 3 mg cytisinicline treatment dosing regimen in individuals who smoke cigarettes or vape nicotine.
AI Summary
Achieve Life Sciences, Inc. announced that the Data Safety Monitoring Committee (DSMC) has completed its second independent review of the ORCA-OL trial. This study evaluates long-term exposure to a novel 3 mg cytisinicline treatment in individuals who smoke cigarettes or vape nicotine. The DSMC found no unexpected treatment-related adverse events and noted excellent medication adherence among trial participants. The safety data remained consistent with previous findings, allowing the trial to continue without any modifications.
These positive findings boost confidence in the safety profile of cytisinicline and support Achieve’s planned submission of a New Drug Application (NDA) in the second quarter of 2025. The company believes this progress will help provide a new prescription treatment option to aid smoking cessation and address the challenges of nicotine dependence.
Read Announcement- Drug:
- ORCA-OL
- Announced Date:
- October 10, 2024
- Indication:
- For smoking cessation and nicotine dependence,
Announcement
Achieve Life Sciences, Inc announced an update on the ORCA-OL clinical trial, evaluating long-term exposure of the novel 3 mg cytisinicline treatment dosing regimen in individuals who smoke cigarettes or vape nicotine.
AI Summary
Achieve Life Sciences, Inc. recently announced an update on its ORCA-OL clinical trial, which is testing the long-term use of a new 3 mg cytisinicline dosing regimen in individuals who smoke or vape nicotine. The trial has successfully enrolled 479 participants across 29 clinical sites in the United States, all of whom were previously involved in the company’s earlier smoking and vaping cessation studies. This rapid enrollment is seen as a strong indication of the urgent need for new smoking cessation treatments.
The first review by the Data Safety Monitoring Committee confirmed that there are no safety concerns with the treatment and the trial will proceed as planned without modifications. The data collected will help meet the U.S. Food and Drug Administration’s requirement for safety information and supports Achieve’s goal of filing a New Drug Application by the first half of 2025.
Read Announcement- Drug:
- ORCA-OL
- Announced Date:
- May 29, 2024
- Indication:
- For smoking cessation and nicotine dependence,
Announcement
Achieve Life Sciences, Inc announced it has initiated screening of subjects for the open-label ORCA-OL clinical trial.
AI Summary
Achieve Life Sciences, Inc. has started screening subjects for its open-label ORCA-OL clinical trial. This study will evaluate the long-term safety of the 3 mg cytisinicline treatment, given three times daily, for adults in the United States who currently smoke or use nicotine e-cigarettes. The trial aims to collect safety data from at least 300 subjects treated over six months, with further data expected from 100 subjects treated for one year. The findings will be an important part of the data package for the planned New Drug Application submission. Recruitment is focused on participants from previous ORCA trials, particularly those who have relapsed or continue to use nicotine products. Achieve’s quick enrollment response from these participants is a positive sign as the company works towards regulatory submission and eventually, potential approval for cytisinicline in the United States.
Read Announcement
Cytisinicline FDA Regulatory Timeline and Events
Cytisinicline is a drug developed by Achieve Life Sciences for the following indication: For the treatment of nicotine dependence.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- cytisinicline
- Announced Date:
- October 17, 2025
- Indication:
- For the treatment of nicotine dependence
Announcement
Achieve Life Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has awarded the company a Commissioner's National Priority Voucher (CNPV) for cytisinicline as a treatment of nicotine dependence for e-cigarette or vaping cessation.
AI Summary
Achieve Life Sciences announced that the U.S. Food and Drug Administration has awarded it a Commissioner’s National Priority Voucher for cytisinicline, aimed at treating nicotine dependence for e-cigarette or vaping cessation. This first-of-its-kind designation, granted to only nine therapies in the program’s inaugural year, provides enhanced FDA communication and an expedited review process that could reduce assessment time to one to two months instead of the typical ten to twelve, once all materials are submitted.
Cytisinicline is a potential first-in-class pharmacotherapy specifically designed to help the roughly 17 million adult e-cigarette users in the U.S., about 60 percent of whom want to quit. If approved, it would fill a major gap, as there are currently no FDA-approved treatments indicated solely for vaping cessation.
In the Phase 2 ORCA-V1 trial, participants receiving cytisinicline were 2.6 times more likely to stop vaping than those on placebo. The FDA has granted Breakthrough Therapy designation for this indication and agreed on the Phase 3 ORCA-V2 trial design, moving Achieve closer to delivering the first FDA-approved vaping cessation medication.
Read Announcement- Drug:
- cytisinicline
- Announced Date:
- September 22, 2025
- Indication:
- For the treatment of nicotine dependence
Announcement
Achieve Life Sciences, Inc. announced the publication of new data in Thorax demonstrating that cytisinicline significantly improved smoking quit rates compared to placebo in adults with and without chronic obstructive pulmonary disease (COPD).
AI Summary
Achieve Life Sciences announced the publication of new data in Thorax showing that cytisinicline significantly improved smoking quit rates versus placebo in adults with and without chronic obstructive pulmonary disease (COPD).
The paper “Cytisinicline for smoking cessation in individuals with self-reported COPD” reports a post hoc analysis of over 1,600 participants in two large, randomized Phase 3 trials, ORCA-2 and ORCA-3.
In COPD patients, cytisinicline doubled quit odds and delivered quit rates comparable to non-COPD smokers. The drug showed robust continuous abstinence in both groups, with no serious treatment-related adverse events and low rates of common side effects.
Dr. Judith Prochaska highlighted the increased quitting odds and excellent tolerability in this high-risk group. Dr. Mark Rubinstein said these results offer clinicians a safe, effective way to help millions of COPD smokers quit.
Read Announcement- Drug:
- cytisinicline
- Announced Date:
- September 3, 2025
- Indication:
- For the treatment of nicotine dependence
Announcement
Achieve Life Sciences, Inc announced that the U.S. Food and Drug Administration (FDA) has accepted the cytisinicline New Drug Application (NDA) for a new treatment for smoking cessation in adults.
AI Summary
Achieve Life Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for cytisinicline, a treatment to help adults quit smoking. Acceptance of the NDA starts the review process and sets a Prescription Drug User Fee Act (PDUFA) target date of June 20, 2026.
The application is supported by pivotal Phase 3 ORCA-2 and ORCA-3 clinical trials, which enrolled more than 2,000 participants. These studies found that cytisinicline, given alongside behavioral support for six or twelve weeks, led to significantly higher smoking abstinence rates at the end of treatment and maintained abstinence through 24 weeks compared to placebo. Safety data from over 600 participants showed no new concerns.
FDA acceptance validates Achieve’s research and brings a potential first new smoking cessation pharmacotherapy in nearly two decades. If approved, cytisinicline could help millions of Americans quit.
Read Announcement- Drug:
- cytisinicline
- Announced Date:
- June 26, 2025
- Indication:
- For the treatment of nicotine dependence
Announcement
Achieve Life Sciences, Inc. announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for cytisinicline as a treatment of nicotine dependence for smoking cessation in adults.
AI Summary
Achieve Life Sciences, Inc. recently submitted a New Drug Application (NDA) to the U.S. FDA for cytisinicline, a promising treatment designed to address nicotine dependence in adults who smoke. This submission, which follows a decade of intensive research, is backed by data from over 2,000 clinical trial participants across two Phase 3 studies. The trials showed that when used alongside standard behavioral support, cytisinicline led to significantly improved smoking cessation rates, as well as a well-tolerated safety and efficacy profile compared to placebo.
If approved, cytisinicline would mark the first new FDA-approved pharmacotherapy for nicotine dependence in twenty years. Achieve Life Sciences hopes this new therapeutic option will provide healthcare providers and patients a much-needed tool to combat the serious health challenges associated with smoking.
Read Announcement
Cytisinicline (ORCA-3) FDA Regulatory Events
Cytisinicline (ORCA-3) is a drug developed by Achieve Life Sciences for the following indication: Smoking Cessation.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Cytisinicline (ORCA-3)
- Announced Date:
- April 21, 2025
- Target Action Date:
- June 1, 2025
- Estimated Target Date Range:
- June 1, 2025 - June 30, 2025
- Indication:
- Smoking Cessation
Announcement
Achieve Life Sciences, Inc. announced that Cytisinicline New Drug Application (NDA) Submission to FDA Planned for June 2025
AI Summary
Achieve Life Sciences, Inc. has announced that it plans to submit a New Drug Application (NDA) for its investigational drug, cytisinicline, to the FDA in June 2025. Cytisinicline is designed to treat nicotine dependence by targeting specific nicotine receptors in the brain, which can reduce cravings and help smokers quit more successfully. Recent trial results from the ORCA-3 study have shown promising outcomes, with cytisinicline significantly increasing quitting rates and reducing nicotine cravings compared to a placebo.
The company hopes that this submission will lead to the approval of a new, well-tolerated treatment option for smoking cessation. By focusing on the targeted action of cytisinicline, Achieve Life Sciences aims to offer a treatment that minimizes side effects common with other therapies, potentially helping many individuals overcome nicotine addiction.
Read Announcement- Drug:
- Cytisinicline (ORCA-3)
- Announced Date:
- April 21, 2025
- Indication:
- Smoking Cessation
Announcement
Achieve Life Sciences, Inc announced that complete trial results from its ORCA-3 were published in the Journal of the American Medical Association (JAMA) Internal Medicine. ORCA-3 was the second randomized, placebo-controlled Phase 3 clinical trial evaluating cytisinicline for smoking cessation in 792 U.S. adults.
AI Summary
Achieve Life Sciences, Inc. announced that the complete trial results from its ORCA-3 study have been published in the Journal of the American Medical Association (JAMA) Internal Medicine. The ORCA-3 trial was the second randomized, placebo-controlled Phase 3 study evaluating cytisinicline for smoking cessation in 792 U.S. adults. Results showed that cytisinicline significantly increased the odds of quitting smoking compared to placebo, while also reducing nicotine cravings during treatment periods of 6 and 12 weeks, with benefits extending through 24 weeks. The trial further confirmed cytisinicline’s targeted effect on nicotine receptors with limited off-target activity, contributing to a favorable tolerability profile. These findings add critical evidence supporting cytisinicline’s potential as a highly effective treatment for nicotine dependence, and Achieve plans to submit its New Drug Application (NDA) to the FDA in June 2025.
Read Announcement
Cytisinicline (ORCA-V1) FDA Regulatory Events
Cytisinicline (ORCA-V1) is a drug developed by Achieve Life Sciences for the following indication: Nicotine E-cigarette Cessation.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Cytisinicline (ORCA-V1)
- Announced Date:
- July 31, 2024
- Indication:
- Nicotine E-cigarette Cessation
Announcement
Achieve Life Sciences, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for cytisinicline for nicotine e-cigarette, or vaping, cessation.
AI Summary
Achieve Life Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for its investigational drug cytisinicline, specifically targeting nicotine vaping cessation. This designation is a significant milestone because it is intended to speed up the development and review process for promising treatments addressing serious or life-threatening conditions. According to Dr. Cindy Jacobs, the company's President and Chief Medical Officer, cytisinicline could become the first approved treatment designed to help more than 13 million Americans who vape nicotine overcome their addiction. The designation allows Achieve Life Sciences enhanced dialogue with senior FDA managers and expert reviewers, facilitating a more efficient path toward potential approval. This move emphasizes the urgent need for effective therapies as vaping continues to present serious health challenges, particularly among adults and potentially adolescents in the future.
Read Announcement
