Last reviewed 2026-05-25 · How we verify

IM haloperidol plus lorazepam

National Taiwan University Hospital · Phase 3 active Small molecule Under review Quality 0/100

IM haloperidol plus lorazepam is a Antipsychotic + benzodiazepine combination Small molecule drug developed by National Taiwan University Hospital. It is currently in Phase 3 development for Acute agitation or psychotic symptoms requiring rapid parenteral intervention, Acute exacerbation of schizophrenia or bipolar disorder. Also known as: haldol and ativan.

IM haloperidol blocks dopamine receptors to reduce psychotic symptoms, while lorazepam enhances GABA signaling to provide sedation and anxiolysis.

Haloperidol is a serotonin 2a (5-HT2a) receptor antagonist, classified as an antagonist and a small molecule. It is used to treat conditions such as psychosis, agitation, delirium, schizophrenia, and schizoaffective disorder, often in combination with other medications.

Likelihood of approval

55.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% 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	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+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	IM haloperidol plus lorazepam
Also known as	haldol and ativan
Sponsor	National Taiwan University Hospital
Drug class	Antipsychotic + benzodiazepine combination
Target	Dopamine D2 receptor (haloperidol); GABA-A receptor (lorazepam)
Modality	Small molecule
Therapeutic area	Psychiatry / Behavioral Health
Phase	Phase 3

Mechanism of action

Haloperidol is a typical antipsychotic that antagonizes dopamine D2 receptors in the mesolimbic and mesocortical pathways, effectively reducing hallucinations and delusions. Lorazepam is a benzodiazepine that potentiates GABA-A receptor activity, producing rapid sedation and anxiolytic effects. This combination is used for acute agitation or psychotic episodes requiring rapid behavioral control.

Approved indications

Acute agitation or psychotic symptoms requiring rapid parenteral intervention
Acute exacerbation of schizophrenia or bipolar disorder

Common side effects

Sedation
Extrapyramidal symptoms (dystonia, akathisia, parkinsonism)
Orthostatic hypotension
Respiratory depression (with lorazepam)
Injection site reactions

Key clinical trials

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:

IM haloperidol plus lorazepam CI brief — competitive landscape report
IM haloperidol plus lorazepam updates RSS · CI watch RSS
National Taiwan University Hospital portfolio CI

Frequently asked questions about IM haloperidol plus lorazepam

What is IM haloperidol plus lorazepam?

IM haloperidol plus lorazepam is a Antipsychotic + benzodiazepine combination drug developed by National Taiwan University Hospital, indicated for Acute agitation or psychotic symptoms requiring rapid parenteral intervention, Acute exacerbation of schizophrenia or bipolar disorder.

How does IM haloperidol plus lorazepam work?

IM haloperidol blocks dopamine receptors to reduce psychotic symptoms, while lorazepam enhances GABA signaling to provide sedation and anxiolysis.

What is IM haloperidol plus lorazepam used for?

IM haloperidol plus lorazepam is indicated for Acute agitation or psychotic symptoms requiring rapid parenteral intervention, Acute exacerbation of schizophrenia or bipolar disorder.

Who makes IM haloperidol plus lorazepam?

IM haloperidol plus lorazepam is developed by National Taiwan University Hospital (see full National Taiwan University Hospital pipeline at /company/national-taiwan-university-hospital).

Is IM haloperidol plus lorazepam also known as anything else?

IM haloperidol plus lorazepam is also known as haldol and ativan.

What drug class is IM haloperidol plus lorazepam in?

IM haloperidol plus lorazepam belongs to the Antipsychotic + benzodiazepine combination class. See all Antipsychotic + benzodiazepine combination drugs at /class/antipsychotic-benzodiazepine-combination.

What development phase is IM haloperidol plus lorazepam in?

IM haloperidol plus lorazepam is in Phase 3.

What are the side effects of IM haloperidol plus lorazepam?

Common side effects of IM haloperidol plus lorazepam include Sedation, Extrapyramidal symptoms (dystonia, akathisia, parkinsonism), Orthostatic hypotension, Respiratory depression (with lorazepam), Injection site reactions.

What does IM haloperidol plus lorazepam target?

IM haloperidol plus lorazepam targets Dopamine D2 receptor (haloperidol); GABA-A receptor (lorazepam) and is a Antipsychotic + benzodiazepine combination.

Drug class: All Antipsychotic + benzodiazepine combination drugs
Target: All drugs targeting Dopamine D2 receptor (haloperidol); GABA-A receptor (lorazepam)
Manufacturer: National Taiwan University Hospital — full pipeline
Therapeutic area: All drugs in Psychiatry / Behavioral Health
Indication: Drugs for Acute agitation or psychotic symptoms requiring rapid parenteral intervention
Indication: Drugs for Acute exacerbation of schizophrenia or bipolar disorder
Also known as: haldol and ativan

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