Drugs / PERPHENAZINE 4-AMINOBUTYRATE
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00480246 | May 2007 → ? | — | BioLineRx, Ltd. | Completed | No outcome recorded |
| Phase 23 trials · 1 met primary | ||||||
| Phase 2 | NCT00567710 | Jul 2008 → Jul 2009 | schizophrenia | BioLineRx, Ltd. | Completed | Met primary |
| Phase 2 | NCT00722176 | Jun 2008 → Jul 2009 | schizophrenia | BioLineRx, Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT00480571 | Jun → Dec 2007 | schizoaffective disorder, schizophrenia | BioLineRx, Ltd. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2013-03-20 | BioLineRx, Ltd. | Results BioLineRx Announces Results from Interim Analysis of Phase II/III CLARITY Trial of BL-1020 for Schizophrenia biolinerx.com ↗
After conferring with the study’s independent Data Monitoring Committee (DMC), the Company has decided to discontinue the CLARITY study. |
| 2012-10-09 | BioLineRx, Ltd. | Results BioLineRx Announces New Analysis of EAGLE Phase IIb Study Showing a Significantly Greater Beneficial Effect of BL-1020 on Cognitive Function in Schizophrenia Patients biolinerx.com ↗
Results of the re-analysis clearly show that when the time of day for administration of the neurocognitive BACS test was consistent between visits, the beneficial effect of BL-1020 on cognitive function was even more pronounced than the original analysis. |
| 2012-09-27 | BioLineRx, Ltd. | Results BioLineRx Announces Publication of EAGLE Study Results Demonstrating BL-1020's Efficacy in Improving Cognitive Function in Schizophrenia Patients biolinerx.com ↗
The findings, which were originally announced in September 2009, were published in the September 2012 issue of the Journal of Clinical Psychiatry. |
| 2011-11-22 | BioLineRx, Ltd. | Regulatory BioLineRx Announces Receipt of Approval in India to Commence Phase II/III CLARITY Clinical Trial of BL-1020 for Treatment of Schizophrenia biolinerx.com ↗
BioLineRx (NASDAQ:BLRX; TASE:BLRX), a biopharmaceutical development company, announced today that it has received approval from the Indian regulatory authorities and the Indian local ethics committees to commence the Phase II/III CLARITY clinical trial of BL-1020, a first in class, orally available, GABA-enhanced antipsychotic for the treatment of schizophrenia. |
| 2011-09-27 | BioLineRx, Ltd. | Results BioLineRx to Present Data from the Successfully Completed Phase IIb trial of BL-1020 at European Conference on Schizophrenia Research biolinerx.com ↗
The Phase IIb EAGLE trial data demonstrate that BL-1020 is effective at treating schizophrenia symptoms with a good safety profile. |
| 2010-01-17 | BioLineRx, Ltd. | Results BioLineRx Announces Positive Results from Its Phase 2b EAGLE Extension Trial Assessing the Safety and Efficacy of BL-1020 biolinerx.com ↗
The new results show that patients receiving BL-1020 (20-30mg/day) for 6 additional weeks maintained the improvements in PANSS and CGI (widely recognized measures of severity and improvement in schizophrenia) after 6 weeks of treatment and, more importantly, showed an additional improvement in cognitive function as assessed by BACS (“Brief Assessment of Cognition in Schizophrenia”). |
| 2009-09-24 | BioLineRx, Ltd. | Results EAGLE Trial Signals Breakthrough in the Treatment of Schizophrenia biolinerx.com ↗
BL-1020 exhibited statistical significance to both the placebo and Risperidone control groups (p=0.027 for both). |
| 2009-09-14 | BioLineRx, Ltd. | Results BioLineRx Announces Positive Topline Results for BL-1020, a First in Class GABA Enhanced Antipsychotic for the Treatment of Schizophrenia biolinerx.com ↗
BioLineRx announced today top line results from its phase 2b EAGLE (Effective Antipsychosis via GABA Level Enhancement) study assessing the efficacy, safety and tolerability of BL-1020, conducted under a US FDA IND (Investigational New Drug). |
| 2009-06-21 | BioLineRx, Ltd. | Results BioLineRx Announces New Results Confirming the Mode of Action of Its Anti-Psychotic Drug- BL-1020 biolinerx.com ↗
Recent pre-clinical studies clearly show that BL-1020 reverses cognitive impairment and that this reversal is mediated by the GABA moiety of BL-1020. |
| 2009-05-18 | BioLineRx, Ltd. | Results BioLineRx presents data at SOBP demonstrating the potential benefit of BL-1020 in improving cognition biolinerx.com ↗
The ability of BL1020 to improve episodic memory deficits suggests potential for the treatment of cognitive deficits in schizophrenia. |
All press releases naming this drug 10 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PERPHENAZINE 4-AMINOBUTYRATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL1187646 ↗ |
| Known as | BL-1020 | “BL-1020 is a γ-aminobutyric acid (GABA)-enhanced antipsychotic that combines dopamine antagonism with GABA agonist activity.” PMID 23059159 ↗ Sep 2012 |
| Modality | Small molecule | — CHEMBL1187646 ↗ |
| Route | Oral | “single oral doses of BL-1020 or Perphenazine” NCT00480246 ↗ |