31 completed, 4 terminated, 1 not yet recruiting, 1 unknown. 18 Phase 2, 12 Phase 1, 9 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 18 | Completed 15, Terminated 2, Unknown 1 |
| Phase 1 | 12 | Completed 11, Terminated 1 |
| Phase 3 | 9 | Completed 6, Terminated 2, Not yet recruiting 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Phase 3 Trial Evaluating the Efficacy and Safety of Cytisinicline for Vaping Cessation in Adults Using Nicotine-Containing E Cigarettes Cytisinicline, Placebo, Behavioral Support - Vaping Cessation | Phase 3 | Not yet recruiting | Achieve Life Sciences | 800 | 2026-05-15 | 2026-02-06 |
| Safety Study of Cytisinicline in Adult Combustible and/or E-cigarette Smokers Cytisinicline - Smoking Cessation, Vaping Cessation | Phase 3 | Completed | Achieve Life Sciences | 479 | 2024-05-28 | 2025-11-26 |
| Study to Evaluate Effect of Food on Bioavailability of Single 3 mg Tablet and Pharmacokinetics (PK) of Multiple 3 mg Doses in Healthy Adult Smokers Cytisinicline - Smoking Cessation | Phase 1 | Completed | Achieve Life Sciences | 30 | 2023-08-08 | 2023-10-18 |
| Study to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics of a Single 3 mg Cytisinicline Dose cytisinicline - Renal Impairment | Phase 1 | Completed | Achieve Life Sciences | 44 | 2023-01-10 | 2025-07-11 |
| Study to Evaluate Electrocardiographic Effects of Therapeutic & Supratherapeutic Doses of Cytisinicline in Healthy Smokers Cytisinicline, Placebo, Moxifloxacin - Smoking Cessation | Phase 1 | Completed | Achieve Life Sciences | 27 | 2022-10-17 | 2023-05-18 |
| A Study of Cytisinicline for Vaping Cessation in Adult Smokers cytisinicline, Placebo, Behavioral support - Vaping, E-Cig Use | Phase 2 | Completed | Achieve Life Sciences | 160 | 2022-07-13 | 2026-01-14 |
| A Second Study of Cytisinicline for Smoking Cessation in Adult Smokers Cytisinicline, Placebo, Behavioral support - Smoking Cessation | Phase 3 | Completed | Achieve Life Sciences | 792 | 2022-01-20 | 2026-01-14 |
| A Study of Cytisinicline for Smoking Cessation in Adult Smokers Cytisinicline, Placebo, Behavioral support - Smoking Cessation | Phase 3 | Completed | Achieve Life Sciences | 810 | 2020-10-13 | 2026-01-15 |
| A Single Dose-escalation Study of Cytisine in Adult Smokers cytisine, placebo - Smoking Cessation | Phase 1 | Completed | Achieve Life Sciences | 74 | 2019-02-28 | 2020-09-17 |
| Trial of Cytisine in Adult Smokers Cytisine, Placebo Comparator, Behavioral support - Smoking Cessation | Phase 2 | Completed | Achieve Life Sciences | 254 | 2018-11-13 | 2020-05-18 |
| A Study in Healthy Smokers to Investigate the Effect of Food on the Bioavailability of Cytisine in a New Formulation cytisine - Smoking Cessation | Phase 1 | Completed | Achieve Life Sciences | 13 | 2018-04-27 | 2019-09-24 |
| A Pharmacokinetic and Pharmacodynamic Evaluation of Cytisine in Healthy Smokers Cytisine - Smoking Cessation | Phase 1 / Phase 2 | Terminated | Achieve Life Sciences | 26 | 2017-10-06 | 2019-10-21 |
| A Study in Healthy Volunteers to Investigate the Effect of Food on the Bioavailability of Cytisine Cytisine - Smoking Cessation | Phase 1 | Completed | Achieve Life Sciences | 24 | 2017-08-08 | 2019-02-26 |
| Study of Gemcitabine/Carboplatin First-line Chemotherapy +/- Apatorsen in Advanced Squamous Cell Lung Cancers Apatorsen (OGX-427), Gemcitabine, Carboplatin - Squamous Cell Lung Cancer | Phase 2 | Unknown | Queen Mary University of London | 140 | 2014-06-01 | 2017-08-22 |
| Phase II Trial Of Gemcitabine Plus Nab-Paclitaxel +/- OGX-427 In Patients With Metastatic Pancreatic Cancer OGX-427, Placebo - Pancreatic Cancer | Phase 2 | Completed | SCRI Development Innovations, LLC | 132 | 2013-09-01 | 2017-05-16 |
| Phase II Trial of Carboplatin and Pemetrexed +/- OGX-427 in Untreated Stage IV Non-Squamous-Non-Small-Cell Lung Cancer OGX-427, Placebo - Non Squamous Non Small Cell Lung Cancer | Phase 2 | Completed | SCRI Development Innovations, LLC | 155 | 2013-07-01 | 2018-06-08 |
| Thorough QT/QTc (Corrected QT Interval) Study to Evaluate the Effect of Custirsen on Cardiac Repolarization Custirsen, Placebo, Moxifloxacin - Cardiac Conduction and Repolarization | Phase 1 | Completed | Achieve Life Sciences | 155 | 2013-05-01 | 2016-10-10 |
| Phase 2 Study of Docetaxel +/- OGX-427 in Patients With Relapsed or Refractory Metastatic Bladder Cancer OGX-427, Docetaxel - Bladder Cancer, Urothelial Carcinoma | Phase 2 | Completed | Noah Hahn, M.D. | 200 | 2013-04-01 | 2022-07-11 |
| OGX-427 in Metastatic Castrate-Resistant Prostate Cancer With Prostate-Specific Antigen Progression While Receiving Abiraterone OGX-427, Abiraterone Acetate, Prednisone - Prostate Cancer, Metastatic Castrate-Resistant Prostate Cancer | Phase 2 | Terminated | Costantine Albany | 72 | 2012-12-01 | 2022-07-11 |
| A Multinational, Randomized, Open-Label Study of Custirsen In Patients With Advanced or Metastatic (Stage IV) Non-Small Cell Lung Cancer Custirsen, Docetaxel - Non-Small Cell Lung Cancer | Phase 3 | Completed | Achieve Life Sciences | 664 | 2012-10-24 | 2026-04-15 |
Showing 20 of 37. Sign in to see all of them.
Smoking Cessation (10) · Prostatic Neoplasms (5) · Carcinoma, Non-Small-Cell Lung (4) · Breast Neoplasms (3) · Carcinoma, Transitional Cell (3) · Lung Neoplasms (3) · Neoplasm Metastasis (3) · Neoplasms (3) · Urinary Bladder Neoplasms (3) · Pancreatic Neoplasms (2) · Urologic Neoplasms (2) · Colorectal Neoplasms (1) · Ovarian Neoplasms (1) · Pelvic Neoplasms (1) · Renal Insufficiency (1)
cytisine (13) · OGX-011 (8) · apatorsen (8) · Behavior Therapy (5) · Docetaxel (5) · Prednisone (5) · Carboplatin (3) · Paclitaxel (3) · Gemcitabine (2) · Moxifloxacin (2) · cabazitaxel (2) · Abiraterone Acetate (1) · Cisplatin (1) · Dexamethasone (1) · Saline Solution (1)
United States (22) · Canada (9) · United Kingdom (7) · Russia (5) · Spain (5) · France (4) · Portugal (4) · Germany (3) · Hungary (3) · Italy (3) · Australia (2) · Israel (2) · Poland (2) · South Korea (2) · Belgium (1)
Marlene Fonseca, MD (3) · Annelize Koch, MD (2) · Daniel Cain, Vice-President Clinical Research (2) · Julie Ball (2) · Celestia Higano, MD (1) · Constantine Albany, M.D. (1) · Daniel Petrylak, MD (1) · David R. Spigel, M.D. (1) · Eric Winquist, MD, MSc (1) · Ezanul Abd Wahab, MD (1) · Fred Saad, MD, FRCS (1) · Janessa Laskin, M.D. (1) · Joachim Von Pawel, MD (1) · Johann de Bono, Professor (1) · Johanna Bendell, M.D. (1)
PMID 40962497, PMID 21788353, PMID 22198426, PMID 24156019, PMID 24722180, PMID 27022067, PMID 28283282, PMID 28935773, PMID 29033099, PMID 37432430, PMID 38709500, PMID 40257755
2017 (1), 2018 (1)