Drugs / Laquinimod
Laquinimod
also known as
ABR-215062 · ABR-215062 FREE ACID · ABR-215062 SODIUM · LAQUINIMOD SODIUM · Laquinimod sodium salt · Nerventra · TV-5600 · TV-5600 FREE ACID
Small molecule targets BAX via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Rejected relapsing-remitting multiple sclerosis 1 milestone | |||||
| Refused (EMA) | EU (EMA) | NERVENTRA | relapsing-remitting multiple sclerosis | 2014-01-23 | “negative opinion for the treatment of relapsing-remitting multiple sclerosis (RRMS) by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).” tevapharm.com ↗ |
| Rejected Indication not stated 1 milestone | |||||
| Refused (EMA) | EU (EMA) | Nerventra | — | 2014-08-19 | europa.eu ↗ |
Trials 16
News releases announcing trial results or a regulatory action · 32
| Date | Issuer | Release |
|---|---|---|
| 2017-05-05 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva and Active Biotech Announce CONCERTO trial of Laquinimod in RRMS Did Not Meet Primary Endpoint tevapharm.com ↗
The primary endpoint in CONCERTO -- the evaluation of laquinimod (0.6 mg/daily capsules) versus placebo to evaluate the time to Confirmed Disability Progression (CDP) after at least 3 months – was not met. |
| 2016-01-04 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva and Active Biotech Announce Discontinuation of Higher Doses of Laquinimod in Two Multiple Sclerosis Trials tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and Active Biotech (NASDAQ Stockholm:ACTI) today announced the discontinuation of higher doses of laquinimod in two ongoing studies in multiple sclerosis after the occurrence of cardiovascular events, none of which was fatal, in eight patients. |
| 2014-09-12 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Presents New Clinical Safety Data in RRMS Patients Treated with Laquinimod for Two or More Years at Joint ACTRIMS-ECTRIMS Meeting tevapharm.com ↗
In the pooled safety analysis, rates of adverse events (AEs) and serious AEs were lower in the open-label extensions than in the core studies and less than three percent of patients discontinued treatment due to AEs during these extensions. |
| 2014-05-23 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva and Active Biotech to Continue with the Development of Nerventra® (Laquinimod) for Multiple Sclerosis Following Confirmation of CHMP Opinion tevapharm.com ↗ |
| 2014-04-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Shares New Data on MS Therapies at 66th American Academy of Neurology (AAN) Annual Meeting tevapharm.com ↗
Analyses of Phase III laquinimod studies provide additional clinical insight |
| 2014-01-24 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva and Active Biotech Remain Committed to the Development of NERVENTRA® (laquinimod) for Multiple Sclerosis Following the Negative Opinion from the EMA’s CHMP tevapharm.com ↗
The CHMP has concluded that the risk-benefit profile of NERVENTRA is not favorable at this time. |
| 2013-10-04 | Teva Branded Pharmaceutical Products R&D, Inc. | Results New Data Presented at 29th ECTRIMS Congress Reinforce the Clinical Profile of Investigational Laquinimod on Disease Progression and Inflammation in Relapsing-Remitting Multiple Sclerosis tevapharm.com ↗
Results from a post-hoc subgroup analysis of pooled data from the Phase III double-blind ALLEGRO and BRAVO studies showed there were some patients who experienced disease progression without experiencing a relapse during the studies. |
| 2013-10-01 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Newly Published Phase III Exploratory Analysis Suggests Investigational Oral Laquinimod for Multiple Sclerosis May Reduce Brain Damage Caused by Neurodegeneration tevapharm.com ↗
Laquinimod-treated patients accumulated significantly less brain tissue damage caused by neurodegeneration, compared to placebo in MRI analyses |
| 2013-06-12 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva and Active Biotech Report Positive Results from Phase IIa Study of Laquinimod in Active Lupus Nephritis tevapharm.com ↗
Treatment with laquinimod provided an additive effect in improving renal function when combined with current standard of care for active lupus nephritis (mycophenolate mofetil and corticosteroids), compared with standard of care alone. |
| 2013-03-21 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Early versus Delayed Treatment with Laquinimod Demonstrated Significant Reduction in Risk of Disability Progression – Results of Three-Year ALLEGRO Study in Relapsing-Remitting Multiple Sclerosis tevapharm.com ↗ |
| 2013-03-14 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva to Present New Research on CNS Product Portfolio and Pipeline at 2013 American Academy of Neurology Annual Meeting tevapharm.com ↗
Laquinimod Treatment Reverses Cortical and Hippocampus Pathology Due to Inflammatory Demyelination in a Chronic Mouse Model of Multiple Sclerosis |
| 2012-10-22 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Phase IIa Laquinimod Trial Results Show Positive Data for Potential Use in Active Crohn's Disease tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI) today announced the presentation of Phase IIa clinical data for investigational laquinimod in moderate to severe Crohn’s disease (CD). |
| 2012-04-18 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Announces New Data on Central Nervous System Products to Be Presented at 2012 American Academy of Neurology Annual Meeting tevapharm.com ↗
Pooled analyses from the two-year Phase III ALLEGRO and BRAVO studies supporting the benefits of laquinimod in reducing annualized relapse rates, in reducing the risk of both three-month and six-month confirmed disability progression |
| 2012-03-15 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Phase III Study of Teva's Oral Laquinimod Published in the New England Journal of Medicine Demonstrates Clinical Benefits for Multiple Sclerosis Patients tevapharm.com ↗
Phase III ALLEGRO study results showed laquinimod reduced the annual rate of relapses, slowed the progression of disability, and decreased brain tissue loss |
| 2011-10-19 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Investigational Laquinimod Demonstrates Its Potential as a New Oral Treatment For RRMS tevapharm.com ↗
Laquinimod also demonstrated a significant reduction in the risk of disability progression as measured by the Expanded Disability Status Scale (EDSS) (33.5%, p = 0.044) and in MRI-measured brain volume loss (27.5%, p =< 0.0001). |
| 2011-10-14 | Teva Branded Pharmaceutical Products R&D, Inc. | Results New Data on Teva's Copaxone® and Laquinimod to Be Highlighted at ECTRIMS/ACTRIMS tevapharm.com ↗
Additional data from the ALLEGRO study demonstrating the positive impact of laquinimod on disability accumulation and rate of severe relapses, as well as patient-reported outcomes. |
| 2011-08-01 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Results of Phase III BRAVO Trial Reinforce Unique Profile of Laquinimod for Multiple Sclerosis Treatment tevapharm.com ↗
Results showed that the BRAVO study did not achieve its primary endpoint of reducing the annualized relapse rate (p=0.075). |
| 2011-04-11 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Announces Presentation of New Data on Multiple Sclerosis and Parkinson's Disease Treatments at 2011 American Academy of Neurology Annual Meeting tevapharm.com ↗
New preclinical data providing evidence that the novel mechanism of action (MOA) of oral laquinimod addresses the irreversible pathological processes of MS by reducing axonal damage and neurodegeneration. |
| 2011-04-11 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Oral Laquinimod for Multiple Sclerosis Treatment Significantly Reduced Disease Activity and Disability Progression While Providing Good Safety and Tolerability tevapharm.com ↗
Treatment with laquinimod was also associated with a significant reduction in brain tissue loss, as measured by a 33 percent reduction in progression of brain atrophy (p<0.0001). |
| 2010-12-09 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Announces Successful Results of Phase III Study with Oral Laquinimod For Multiple Sclerosis tevapharm.com ↗
Additional clinical endpoints, including significant reduction in disability progression, as measured by Expanded Disability Severity Scale (EDSS), were also achieved. |
| 2010-10-15 | Teva Branded Pharmaceutical Products R&D, Inc. | Results New Data Evaluating Laquinimod for the Treatment of Multiple Sclerosis Demonstrate Neuroprotective Effects tevapharm.com ↗
Laquinimod reverts the disruption of neurogenic processes that can occur with chronic inflammation in the central nervous system (CNS), and is associated with a significant reduction in the percentage of demyelination and axonal damage. |
| 2010-09-20 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Oral Laquinimod Demonstrated Sustained Efficacy and Safety in Patients with Multiple Sclerosis tevapharm.com ↗
The double-blind, multinational study demonstrated the sustained positive benefit-risk profile of laquinimod, which was shown to reduce Gd-enhancing (GdE) T1 lesions, while maintaining a good safety profile. |
| 2010-04-15 | Teva Branded Pharmaceutical Products R&D, Inc. | Results New Data Suggest Oral Laquinimod May Confer Neuroprotection in Addition to Immunomodulation in the Treatment of Multiple Sclerosis tevapharm.com ↗
New data from studies in RRMS patients demonstrate that treatment with laquinimod results in a significant increase in brain derived neurotrophic factor, a key protein responsible for the maintenance of mature neurons. |
| 2009-04-28 | Teva Branded Pharmaceutical Products R&D, Inc. | Results New Data Illustrate Novel Mechanism of Action of Laquinimod, An Oral Compound For The Treatment of Multiple Sclerosis tevapharm.com ↗
Researchers Demonstrate Immunomodulatory Effects of Laquinimod on Disease Activity |
| 2009-04-22 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva to Present New Data on its Innovative Therapies for Multiple Sclerosis and Parkinson's Disease at the Upcoming 2009 American Academy of Neurology Annual Meeting tevapharm.com ↗
Laquinimod Inhibits MOG-Induced Experimental Autoimmune Encephalomyelitis (EAE) in CD4+CD25+ Regulatory T-Cell Depleted Mice |
| 2009-02-12 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Oral Laquinimod for Multiple Sclerosis Granted Fast Track Status by FDA tevapharm.com ↗
We are pleased that the FDA has awarded laquinimod with a Fast Track designation, and are hopeful it will be part of our growing portfolio of innovative therapies. |
| 2008-09-18 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Laquinimod Demonstrated Significant and Sustained Impact on Multiple Sclerosis Disease Activity tevapharm.com ↗
In RRMS patients who switched from placebo to laquinimod, 52 percent reduction in the mean number of GdE lesions was observed (p<0.0007). |
| 2008-09-15 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva to Present New Treatment Data at World Congress for Multiple Sclerosis tevapharm.com ↗
Laquinimod given before and after disease onset reduces inflammatory cell infiltration and demyelination in experimental autoimmune encephalomyelitis |
| 2007-05-01 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Laquinimod, A Novel Oral Compound, Showed Significant Reduction In Disease Activity In Patients With Relapsing - Remitting Multiple Sclerosis (RRMS) tevapharm.com ↗ |
| 2006-09-05 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Laquinimod Phase IIb Trial confirms efficacy and favorable safety profile and shows significant reduction in the rate of inflammatory disease activity tevapharm.com ↗
Laquinimod treatment significantly reduced the rate of inflammatory disease activity, as measured by the cumulative number of Gadolinium enhancing lesions on brain MRI scans after 36 weeks of treatment. |
| 2005-06-28 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva And Active Biotech Announce The Submission Of An Ind To The Fda For Laquinimod, An Oral Product For The Treatment Of Relapsing Ms tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) and Active Biotech AB (Stockholm: ACTI.ST) announced today the submission of an investigational new drug application (IND) to the U.S. Food and Drug Administration (FDA) to initiate a clinical trial in the U.S. with laquinimod to assess drug-drug interaction. |
| 2005-03-22 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva and Active Biotech Announce That Laquinimod Phase II Data Has Been Published Today in Neurology tevapharm.com ↗
It was concluded that daily treatment with laquinimod at a dose of 0.3 mg, reduced the mean cumulative number of active lesions by 44% compared to placebo (p<0.05) |
All press releases naming this drug 46 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 20 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Laquinimod | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06161415 ↗ |
| Known as | ABR-215062 | ChEMBL registry synonym — accepted as the source's own label CHEMBL66092 ↗ |
| Known as | ABR-215062 FREE ACID | ChEMBL registry synonym — accepted as the source's own label CHEMBL66092 ↗ |
| Known as | ABR-215062 SODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL66092 ↗ |
| Known as | LAQUINIMOD SODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL66092 ↗ |
| Known as | Laquinimod sodium salt | ChEMBL registry synonym — accepted as the source's own label CHEMBL66092 ↗ |
| Known as | Nerventra | ChEMBL registry synonym — accepted as the source's own label CHEMBL66092 ↗ |
| Known as | TV-5600 | ChEMBL registry synonym — accepted as the source's own label CHEMBL66092 ↗ |
| Known as | TV-5600 FREE ACID | ChEMBL registry synonym — accepted as the source's own label CHEMBL66092 ↗ |
| Action | Inhibit | “laquinimod reduces the expression of Bax” PMID 27296315 ↗ Jun 2016 |
| Modality | Small molecule | — CHEMBL66092 ↗ |
| Route | Oral | “oral daily 0.3 and 0.6 mg laquinimod” PMID 18572078 ↗ Jun 2008 |
| Target | BAX | “laquinimod reduces the expression of Bax” PMID 27296315 ↗ Jun 2016 |