Last reviewed 2026-05-22 · How we verify

(+/-)-Indeloxazine (INDELOXAZINE)

Phase 2 active Small molecule ✓ Verified May 2026

(+/-)-Indeloxazine (generic name: INDELOXAZINE) is a drug. It is currently in Phase 2 development.

Indeloxazine is thought to work by modulating the activity of certain neurotransmitters in the brain.

(+/-)-Indeloxazine is a small molecule. It is also known by the synonyms INDELOXAZINA and INDELOXAZINE.

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	INDELOXAZINE
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Imagine your brain is a city with many different streets and intersections. Neurotransmitters are like the traffic signals that help different parts of the brain communicate with each other. Indeloxazine is believed to affect these traffic signals, helping to regulate the flow of information and potentially treating certain conditions.

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:

(+/-)-Indeloxazine CI brief — competitive landscape report
(+/-)-Indeloxazine updates RSS · CI watch RSS

Frequently asked questions about (+/-)-Indeloxazine

What is (+/-)-Indeloxazine?

(+/-)-Indeloxazine (INDELOXAZINE) is a Small molecule drug.

How does (+/-)-Indeloxazine work?

Indeloxazine is thought to work by modulating the activity of certain neurotransmitters in the brain.

What is the generic name of (+/-)-Indeloxazine?

INDELOXAZINE is the generic (nonproprietary) name of (+/-)-Indeloxazine.

What development phase is (+/-)-Indeloxazine in?

(+/-)-Indeloxazine is in Phase 2.

Therapeutic area: All drugs in Neuroscience

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