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BL 1020 High Dose
BL 1020 High Dose is a Dopamine D3 receptor antagonist Small molecule drug developed by BioLineRx, Ltd.. It is currently in Phase 2 development for Schizophrenia, Bipolar disorder.
BL 1020 is a dopamine D3 receptor antagonist that modulates dopaminergic signaling in the brain.
BL 1020 is a medication being studied for the treatment of schizophrenia and schizoaffective disorder. It has been compared to risperidone and a placebo in a six-week, randomized, double-blind, placebo-controlled study.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | BL 1020 High Dose |
|---|---|
| Sponsor | BioLineRx, Ltd. |
| Drug class | Dopamine D3 receptor antagonist |
| Target | Dopamine D3 receptor |
| Modality | Small molecule |
| Therapeutic area | Psychiatry |
| Phase | Phase 2 |
Mechanism of action
BL 1020 selectively blocks dopamine D3 receptors, which are implicated in reward processing, motivation, and psychotic symptoms. By antagonizing D3 receptors while having minimal activity at D2 receptors, the drug aims to provide antipsychotic efficacy with potentially improved tolerability compared to conventional antipsychotics that broadly block D2 receptors.
Approved indications
- Schizophrenia
- Bipolar disorder
Common side effects
- Akathisia
- Extrapyramidal symptoms
- Nausea
- Headache
Key clinical trials
- Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020 (PHASE2)
- A Six-week, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center, Phase II Study (PHASE2)
- Safety and Tolerability of BL-1020 in Hospitalized Subjects With Chronic Schizophrenia or Schizo-Affective Disorder (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- BL 1020 High Dose CI brief — competitive landscape report
- BL 1020 High Dose updates RSS · CI watch RSS
- BioLineRx, Ltd. portfolio CI
Frequently asked questions about BL 1020 High Dose
What is BL 1020 High Dose?
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What does BL 1020 High Dose target?
Related
- Drug class: All Dopamine D3 receptor antagonist drugs
- Target: All drugs targeting Dopamine D3 receptor
- Manufacturer: BioLineRx, Ltd. — full pipeline
- Therapeutic area: All drugs in Psychiatry
- Indication: Drugs for Schizophrenia
- Indication: Drugs for Bipolar disorder
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing