Last reviewed · How we verify

Emerex (BUTAPERAZINE)

Phase 2 active Small molecule

Emerex (generic name: BUTAPERAZINE) is a butaperazine drug. It is currently in Phase 2 development.

Butaperazine works by blocking dopamine receptors in the brain, which can help to reduce symptoms of certain psychiatric conditions.

Emerex, also known as butaperazine, is a small molecule drug in the butaperazine class. Its original development is attributed to an unknown entity, and its current ownership is also unclear. The exact target of butaperazine is unknown, and it has not been approved by the FDA for any indications. Butaperazine is considered off-patent, and its commercial status is likely generic. As a result, key safety considerations and pharmacological details are not well-documented.

Likelihood of approval
12.3% vs 15.3% industry baseline
If approved by FDA: likely 2031–2034
Steps remaining: Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • 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).
Predicted approval windows by jurisdiction (conditional on FDA approval)
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 nameBUTAPERAZINE
Drug classbutaperazine
ModalitySmall molecule
Therapeutic areaNeuroscience
PhasePhase 2

Mechanism of action

Think of dopamine as a messenger in the brain that helps us feel pleasure and motivation. When there's too much dopamine, it can lead to symptoms like anxiety, agitation, and hallucinations. Butaperazine helps to calm the brain by blocking these dopamine receptors, which can bring relief from these symptoms.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Frequently asked questions about Emerex

What is Emerex?

Emerex (BUTAPERAZINE) is a butaperazine drug.

How does Emerex work?

Butaperazine works by blocking dopamine receptors in the brain, which can help to reduce symptoms of certain psychiatric conditions.

What is the generic name of Emerex?

BUTAPERAZINE is the generic (nonproprietary) name of Emerex.

What drug class is Emerex in?

Emerex belongs to the butaperazine class. See all butaperazine drugs at /class/butaperazine.

What development phase is Emerex in?

Emerex is in Phase 2.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing