Last reviewed 2026-06-01 · How we verify

Dolisina (DIETHAZINE)

Phase 2 active Small molecule ✓ Verified Jun 2026

Dolisina (generic name: DIETHAZINE) is a drug. It is currently in Phase 2 development.

Dolisina is thought to work by interacting with a specific target in the body to produce a therapeutic effect.

Dolisina is a small molecule with synonyms including DIETAZINA, DIETHAZINE, and DIETHAZINE. Its modality is classified as a small molecule.

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 name	DIETHAZINE
Target	Pleiotropic ABC efflux transporter of multiple drugs
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

While the exact details of how Dolisina works are not well understood, it is believed to affect the brain's chemistry to produce a calming effect. This can help to reduce anxiety and other symptoms associated with certain conditions. However, more research is needed to fully understand its mechanism of action.

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:

Dolisina CI brief — competitive landscape report
Dolisina updates RSS · CI watch RSS

Frequently asked questions about Dolisina

What is Dolisina?

Dolisina (DIETHAZINE) is a Small molecule drug.

How does Dolisina work?

Dolisina is thought to work by interacting with a specific target in the body to produce a therapeutic effect.

What is the generic name of Dolisina?

DIETHAZINE is the generic (nonproprietary) name of Dolisina.

What development phase is Dolisina in?

Dolisina is in Phase 2.

What does Dolisina target?

Dolisina targets Pleiotropic ABC efflux transporter of multiple drugs.

Target: All drugs targeting Pleiotropic ABC efflux transporter of multiple drugs
Therapeutic area: All drugs in Neuroscience

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