Drugs / Nadolol
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | CORGARD | — | 1984-11-16 – 1986-10-28 | fda.gov ↗ |
| Approved | US (FDA) | CORGARD | — | 1979-12-10 | fda.gov ↗ |
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00960245 | Jul 1994 | hypertensive disorder, migraine disorder | Sandoz | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00670267 | Jan 2007 → May 2009 | asthma | Invion, Inc. | Completed | No outcome recorded |
| Phase 24 trials · 1 met primary | ||||||
| Phase 2 | NCT04739423 | Jun 2021 → Jul 2022 | Lewy body dementia, Parkinson disease, REM sleep behavior disorder | CuraSen Therapeutics, Inc. | Completed | Met primary |
| Phase 2 | NCT01825122 | Mar 2014 → Jun 2015 | — | Invion, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01804218 | Mar 2013 → May 2016 | chronic asthma | Invion, Inc. | Unknown | No outcome recorded |
| Phase 2 | NCT01010308 | Nov 2009 → May 2011 | hemangioma | The Hospital for Sick Children | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT05585125 | Feb 2024 → Jul 2026 overdue | diastolic heart failure | Weill Medical College of Cornell University | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT05019027 | Jan 2024 → Mar 2026 overdue | amyloidosis, heart disorder | Weill Medical College of Cornell University | Enrolling by invitation | No outcome recorded |
| Comparator or background therapy15 trials | ||||||
| Phase 0 | NCT06643221 Comparator | Jan 2018 → May 2031 expected | leukemia, lymphoma | University of Arizona | Recruiting | No outcome recorded |
| Phase 1 | NCT00648297 Comparator | Aug 2006 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1 | NCT00647660 Comparator | Jul → Aug 2006 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 3 | NCT02505971 Comparator | Sep 2015 → Apr 2020 | hemangioma | The Hospital for Sick Children | Completed | No outcome recorded |
| Phase 4 | NCT04757584 Comparator | Apr 2021 → Apr 2023 | diastolic heart failure | Weill Medical College of Cornell University | Completed | No outcome recorded |
| Phase 4 | NCT04767061 Comparator | Apr 2021 → Apr 2022 | diastolic heart failure | Weill Medical College of Cornell University | Completed | No outcome recorded |
| Phase 4 | NCT07405229 Comparator | May 2018 → Dec 2032 expected | cardiac arrest, ventricular fibrillation | Bo Gregers Winkel | Recruiting | No outcome recorded |
| Phase 4 | NCT00567216 Comparator | Apr 2007 → Jul 2010 | hepatocellular carcinoma, varicose disease | Taipei Veterans General Hospital, Taiwan | Unknown | No outcome recorded |
| Phase 4 | NCT01103154 Comparator | Mar 2005 → Jan 2010 | esophageal varices with bleeding | E-DA Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00921349 Background | Dec 2004 → May 2009 | cirrhosis of liver, esophageal varices with bleeding | National Science and Technology Council, Taiwan | Completed | No outcome recorded |
| Phase 4 | NCT00910689 Comparator | Jul 2001 → Nov 2005 | migraine disorder | Ohio University | Completed | No outcome recorded |
| Phase 4 | NCT00450164 Background | Nov 2000 → Jun 2004 | cirrhosis of liver, portal hypertension | Sant Pau Research Institute | Completed | No outcome recorded |
| — | NCT07168395 Comparator | Oct 2026 → Nov 2027 expected | — | University of California, Los Angeles | Not yet recruiting | No outcome recorded |
| — | NCT01117454 Background | Dec 2011 → Dec 2015 | catecholaminergic polymorphic ventricular tachycardia | Vanderbilt University Medical Center | Completed | Met primary |
| — | NCT00684489 Comparator | Sep 2003 → Mar 2005 | essential hypertension | Medical University of South Carolina | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2024-03-07 | CuraSen Therapeutics, Inc. | Results CuraSen Therapeutics Announces Oral Presentation of Additional Positive Phase 2a Data with CST-2032/CST-107 in Patients with Alzheimer’s or Parkinson’s Disease at AD/PD™ 2024 International Conference curasen.com ↗
Target effect sizes of 0.2-0.3 or higher, as seen in this study, predict success in larger, longer studies. |
| 2023-03-30 | CuraSen Therapeutics, Inc. | Results CuraSen Therapeutics to Present Phase 2 Data Showing Rapid-Onset Cognition and Mood Benefit with CST-103/CST-107 (Clenbuterol/Nadolol) in Parkinson’s Disease at the Alzheimer’s Disease and Parkinson’s Disease (AD/PD’23) Conference curasen.com ↗
For the first time, we have been able to show improved outcomes in cognition and mood with adrenergic agonism in patients with neurodegenerative disease, by safely restoring a stimulus to the brain that is lost early in the pathologic process. |
| 2016-05-20 | Invion, Inc. | Results Phase 2 data presented to American Thoracic Society inviongroup.com ↗ |
| 2015-11-16 | Invion, Inc. | Results Smoking cessation trial results of ongoing data analysis inviongroup.com ↗
The ongoing analysis, which forms part of the pre-specified statistical analysis plan (SAP), demonstrates that treatment with INV102 (nadolol) shows a statistically significant effect on biomarker MUC5AC independent of an effect on markers of inflammation. |
| 2015-10-06 | Invion, Inc. | Results Dr Glass discusses P2 smoking cessation trial results inviongroup.com ↗
Phase 2 trial data demonstrates INV102 treated smokers were more likely to stop smoking completely or dramatically reduce the number of cigarettes smoked; |
| 2015-10-04 | Invion, Inc. | Results Invion - successful completion of P2 study of INV102 inviongroup.com ↗
Summary data from the randomised, double blinded , placebo controlled study released today shows smokers administered INV102 were more likely to stop smoking completely, or dramatically reduce the number of cigarettes smoked. |
| 2015-05-18 | Invion, Inc. | Results Oral nadolol data presented to American Thoracic Society inviongroup.com ↗
Lead study investigators Dr Mario Castro and Geneline Sajol from Washington University further noted that oral nadolol could be safely administered to smokers experiencing chronic cough and not just patients diagnosed with chronic obstructive pulmonary disorder (COPD). |
| 2015-03-22 | Invion, Inc. | Regulatory Pre-IND status for inhaled INV102 (nadolol) inviongroup.com ↗
Further, the FDA has accepted Invion’s two Phase 1 study outlines and proposed toxicology program. |
| 2015-01-18 | Invion, Inc. | Results Invion announces interim data in smoking cessation trial inviongroup.com ↗
The blind-broken analysis shows clinically relevant changes in four biomarkers of inflammation in INV102 (nadolol) treated patients compared to placebo. |
| 2014-09-22 | Invion, Inc. | Results Phase 2 asthma trial interim blinded data inviongroup.com ↗
During initial titration and through the three months of stable daily dosing, patients demonstrated no requirement to increase rescue medication u sage – provided either as a short-acting beta-agonist (SABA) or as an anti-muscarinic agent; |
| 2014-01-28 | Invion, Inc. | Regulatory FDA lifts hold on smoking cessation trial inviongroup.com ↗
Invion Limited (ASX: IVX) is pleased to announce that the US Food and Drug Administration (FDA) has removed the clinical hold on Invion’s phase II ‘smoking cessation’ clinical trial of INV102 (nadolol) in patients with pre-existing chronic obstructive pulmonary disease (COPD). |
All press releases naming this drug 17 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 23 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | nadolol | “Other names:
acebutolol, atenolol, betaxolol, bisoprolol, carvedilol, labetalol, metoprolol, metoprolol succinate, metoprolol tartrate, nadolol, nebivolol, propranolol,...” NCT05585125 ↗22“Other Names: * acebutolol * atenolol * betaxolol * bisoprolol * carvedilol * labetalol * metoprolol succinate * metoprolol tartrate * nadolol * nebivolol * penbutolol *...” NCT05019027 ↗ “A non-selective betablocker: Propranolol Retard 80 mg daily or Nadolol 40 mg daily OR 2) A selective betablocker: Atenolol 25 mg daily, Bisoprolol 2.5 mg daily or Metoprolol 50 mg.” NCT07405229 ↗ “Standard therapy with beta-blocker (nadolol, atenolol, metoprolol, or propranolol) continues throughout the trial.” NCT01117454 ↗ “bisoprolol, metoprolol, nadolol, propranolol, timolol” NCT00684489 ↗ “These may include propranolol, nadolol, and timolol.” NCT07168395 ↗ “nadolol” NCT04767061 ↗ “nadolol” NCT04757584 ↗ |
| Known as | CST-107 | “clenbuterol (CST-103) and matching placebo orange capsules; nadolol (CST-107) and matching placebo white capsules” NCT04739423 ↗ |
| Action | Inhibit | “a drug (beta blocker) that blocks stress hormones like adrenaline” NCT06643221 ↗ |
| Route | Oral | “single, oral 80 mg/5 mg (1 x 80 mg/5 mg) dose administered under fasting conditions” NCT00647660 ↗ |