dexmecamylamine
Trials 19
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 19 trials | ||||||
| Phase 1 | NCT01500018 | Jan → Apr 2012 | substance abuse | AstraZeneca | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT01458899 | Nov 2011 → Jan 2012 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01403922 | Aug 2011 → Aug 2012 | hypertensive disorder | AstraZeneca | Terminated | No outcome recorded |
| Phase 1 | NCT01392820 | Jul → Oct 2011 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01359618 | Jun 2011 → Apr 2012 | — | AstraZeneca | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT01239771 | Jan → May 2011 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01240967 | Nov 2010 → Jul 2011 | impaired renal function disease | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01175564 | Jul → Sep 2010 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01145768 | Jun → Aug 2010 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00899977 | May → Aug 2009 | resistant hypertension | Targacept Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 24 trials · 1 missed | ||||||
| Phase 2 | NCT04263623 | Jan → Dec 2020 | hyperhidrosis palmaris ET plantaris, isolated hyperchlorhidrosis | Atacama Therapeutics | Unknown | No outcome recorded |
| Phase 2 | NCT03404570 | Dec 2017 → Jan 2019 | hyperhidrosis palmaris ET plantaris | Atacama Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT01868516 | May 2013 → Jun 2014 | overactive bladder | Targacept Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01288079 | Feb 2011 → Aug 2012 | major depressive disorder | AstraZeneca | Terminated | Missed primary |
| Phase 35 trials · 4 missed | ||||||
| Phase 3 | NCT01197508 | Sep 2010 → Jan 2012 | major depressive disorder | AstraZeneca | Completed | Missed primary |
| Phase 3 | NCT01180400 | Sep 2010 → Sep 2011 | major depressive disorder | AstraZeneca | Completed | Missed primary |
| Phase 3 | NCT01157078 | Jun 2010 → Nov 2011 | major depressive disorder | AstraZeneca | Completed | Missed primary |
| Phase 3 | NCT01152554 | Jun 2010 → Feb 2012 | major depressive disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT01153347 | Jun 2010 → Jan 2012 | major depressive disorder | AstraZeneca | Completed | Missed primary |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT00692445 Comparator | Jun 2008 → May 2009 | major depressive disorder | Targacept Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2012-03-20 | AstraZeneca | Results Remaining TC-5214 Phase III efficacy studies do not meet endpoint, regulatory filing will not be pursued astrazeneca.com ↗
RENAISSANCE 4 and RENAISSANCE 5, both efficacy and tolerability studies, did not meet the primary endpoint of change on the Montgomery-Asberg Depression Rating Scale (MADRS) total score after eight weeks of adjunct treatment with TC-5214 as compared to placebo. |
| 2011-12-20 | AstraZeneca | Results AstraZeneca updates on olaparib and TC-5214 development programmes astrazeneca.com ↗
In addition, AstraZeneca announced that the second RENAISSANCE Phase III study of TC-5214 for patients with major depressive disorder did not meet its primary end point. |
| 2011-11-08 | AstraZeneca | Results AstraZeneca and Targacept announce first top-line Phase III results for TC-5214 as an adjunct treatment in patients with major depressive disorder astrazeneca.com ↗
The study did not meet its primary endpoint of change on the Montgomery-Asberg Depression Rating Scale (MADRS) after eight weeks of treatment with TC-5214 as compared to placebo. |
All press releases naming this drug 6 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 25 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | dexmecamylamine | “This paper reports the efficacy and tolerability of the nicotinic channel modulator TC-5214 (dexmecamylamine) as adjunct therapy for patients with major depressive disorder who...” PMID 24507016 ↗ Dec 20136“Two Phase III randomised double-blind studies of fixed-dose TC-5214 (dexmecamylamine) adjunct to ongoing antidepressant therapy in patients with major depressive disorder and...” PMID 25602163 ↗ Jan 2015 “TC-5214 (dexmecamylamine) is a nicotinic channel modulator that has previously been evaluated for treatment of major depression disorder (MDD) and is currently being evaluated...” PMID 24408516 ↗ Jan 2014 “nicotinic channel modulator dexmecamylamine (TC-5214)” PMID 25514064 ↗ Feb 2015 |
| Known as | Dexmecamilamina | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103881 ↗ |
| Known as | Dexmecamylamine HCl | “Oral tablet containing 2 mg of active drug, dexmecamylamine HCl.” NCT04263623 ↗1“Oral tablet containing 2 mg of active drug, dexmecamylamine HCl.” NCT03404570 ↗ |
| Known as | DEXMECAMYLAMINE HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103881 ↗ |
| Known as | Mecamylamine s-(+)-form hydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103881 ↗ |
| Known as | NIH-11008 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103881 ↗ |
| Known as | S-mecamylamine | “A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Active Controlled, Parallel Group, Multicenter Study to Assess the Safety and Efficacy of 2 Fixed Dose Groups of...” NCT01288079 ↗7“A Multicenter, Randomized, Double-Blind Parallel Group Placebo-Controlled Phase III, Efficacy and Safety Study of 3 Fixed Dose Groups of TC-5214 (S-mecamylamine) as an Adjunct...” NCT01197508 ↗ “A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Phase III Efficacy and Safety Study of TC-5214 (S-mecamylamine) in Flexible Doses as an Adjunct to...” NCT01180400 ↗ “An Open-Label, Multi-Center, Phase I Study To Compare the Pharmacokinetics of a Single Oral Dose of TC-5214 (S-Mecamylamine) in Subjects With Renal Impairment With Subjects...” NCT01240967 ↗ “after a single and repeated oral doses of TC-5214 (S-mecamylamine) in healthy male Japanese subjects” NCT01175564 ↗ “Oral TC-5214 (S-Mecamylamine) After Administration of Single and Multiple Ascending Doses” NCT01145768 ↗ “TC-5214 (S-mecamylamine) as an Adjunct to an Antidepressant” NCT01152554 ↗ “TC-5214 (S-Mecamylamine)” NCT01458899 ↗ |
| Known as | TC-5214 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01152554 ↗ |
| Known as | TC-5214-23 | “TC-5214 (as TC-5214-23) will be provided as white, opaque, hard-gelatin capsules in strengths of 1, 2, and 4 mg.” NCT00692445 ↗ |
| Modality | Other / unclassified | “nicotinic channel modulator dexmecamylamine (TC-5214)” PMID 25514064 ↗ Feb 2015 |
| Route | Oral | “Concentration-time profiles of TC-5214 after either single or multiple oral doses of TC-5214 was described by a one-compartment model with first-order absorption with lag time...” PMID 24408516 ↗ Jan 2014 |