Recent Updates
Recently added Catalysts

BL 1020

Phase 2

Schizophrenia | Small molecule | Psychiatry |BioLineRx Ltd.|Trials Updated: Jun 29, 2010

BL 1020 development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since May 2007

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials3
Total Enrollment670

FDA Designations

No designations recorded

BL 1020 clinical trials

BL 1020 · 3 trials · 2 indications

Phase 2 3
NCT00567710A Six-week, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center, Phase II StudySchizophrenia
COMPLETED360 Analytics
NCT00722176Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020Schizophrenia
COMPLETED220 Analytics
NCT00480571Safety and Tolerability of BL-1020 in Hospitalized Subjects With Chronic Schizophrenia or Schizo-Affective DisorderSchizophrenia
COMPLETED90 Analytics
PHASE2COMPLETED
A Six-week, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center, Phase II Study
SchizophreniaUnlock trial analytics
PHASE2COMPLETED
Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020
SchizophreniaUnlock trial analytics
PHASE2COMPLETED
Safety and Tolerability of BL-1020 in Hospitalized Subjects With Chronic Schizophrenia or Schizo-Affective Disorder
SchizophreniaUnlock trial analytics

Study Endpoints

Primary Endpoints

to evaluate the safety and tolerability of two dose ranges
6 weeks
changes from baseline in vital signs, laboratory and ECG evaluations, physical/neurological examination, Extrapyramidal Symptom Rating Scale (ESRS), and incidence of adverse events (AEs) and adverse drop-outs (ADOs).
6 weeks
To determine the safety and tolerability of two dose ranges (20-40 mg/day, 30-50 mg/day) of BL-1020 tri-mesylate (free base) in subjects with chronic schizophrenia or schizo-affective disorder
6 weeks

Secondary Endpoints

to evaluate the efficacy of two dose ranges
6 weeks
Comparisons between each of the BL-1020 treatment groups and the risperidone group
6 weeks
To determine the MTD, the optimal dose escalation schedule, and the maximum tolerated maintenance dose
6 weeks
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
IEXPERIMENTALBL - 1020 lowdose
IIEXPERIMENTALBL 1020 high dose
IIIPLACEBO_COMPARATOR -
IVACTIVE_COMPARATORRisperidone
1EXPERIMENTALBL-1020 10 mg
2EXPERIMENTALBL-1020 10-30 mg
3ACTIVE_COMPARATORrisperidone

Interventions

NameTypeDescription
BL - 1020DRUG10 mg/day
PlaceboDRUGCapsules
RisperidoneDRUGCapsules
BL-1020DRUG10 mg
BL-1020 10-30 mgDRUGBL-1020 10-30 mg
BL 1020 High DoseDRUGBL 1020 High Dose
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patient is male or female, 18-65 years of age, inclusive. * If female, the patient must be post-menopausal, or if fecund, must be abstinent or practicing an established method of birth control such as hormonal preparations (e.g., oral contraceptive tablets, hormonal implant de...

Countries:United StatesIsraelRomania
Unlock Eligibility Criteria

Frequently asked questions about BL 1020

What is BL 1020?

BL 1020 is an investigational small molecule developed by BioLineRx Ltd. for schizophrenia. It is a Phase 2 candidate that has been studied in three completed clinical trials enrolling a total of 670 participants. It has not been approved and remains in clinical development.

What is BL 1020 used for?

BL 1020 is being developed for the treatment of schizophrenia. One of its Phase 2 trials also enrolled patients with chronic schizophrenia or schizoaffective disorder. All studies of BL 1020 to date have been completed, and the drug remains investigational.

Who is developing BL 1020?

BL 1020 is developed by BioLineRx Ltd., which trades under the ticker BLRX. The company has sponsored three completed Phase 2 trials of the drug in schizophrenia, including a randomized, double-blind, placebo-controlled study and a long-term extension study.

What phase is BL 1020 in?

BL 1020 is in Phase 2 development. All three of its clinical trials were Phase 2 studies, and all have been completed. There are currently no active trials of BL 1020, and the drug is not FDA approved.

What clinical trials is BL 1020 in?

BL 1020 has been evaluated in three completed Phase 2 trials: NCT00722176, a long-term safety, tolerability, and efficacy extension study; NCT00567710, a six-week randomized, double-blind, placebo-controlled study; and NCT00480571, a safety and tolerability study in hospitalized patients.

Is BL 1020 the same as BL-1020?

Yes. BL 1020, BL-1020, BL - 1020, and BL- 1020 all refer to the same investigational compound developed by BioLineRx Ltd. for schizophrenia. The variations are formatting differences in how the drug name is written.