Last reviewed 2026-05-31 · How we verify

Butriptylene (BUTRIPTYLINE)

Phase 2 active Small molecule ✓ Verified May 2026

Butriptylene (generic name: BUTRIPTYLINE) is a butriptyline drug. It is currently in Phase 2 development for Depressive disorder.

Butriptyline works by blocking the reuptake of serotonin, a neurotransmitter involved in mood regulation, allowing more serotonin to be available in the brain.

Butriptylene is a small molecule with an unknown mechanism of action. It is also known by several synonyms, including butriptyline and evadene.

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	BUTRIPTYLINE
Drug class	butriptyline
Target	Sodium-dependent serotonin transporter
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Think of serotonin like a messenger that helps regulate your mood. When serotonin is released, it sends a signal to other parts of the brain. Butriptyline helps keep these messengers in the brain longer by blocking their reabsorption, which can help improve mood and reduce symptoms of depression.

Approved indications

Depressive disorder

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:

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

Frequently asked questions about Butriptylene

What is Butriptylene?

Butriptylene (BUTRIPTYLINE) is a butriptyline drug, indicated for Depressive disorder.

How does Butriptylene work?

Butriptyline works by blocking the reuptake of serotonin, a neurotransmitter involved in mood regulation, allowing more serotonin to be available in the brain.

What is Butriptylene used for?

Butriptylene is indicated for Depressive disorder.

What is the generic name of Butriptylene?

BUTRIPTYLINE is the generic (nonproprietary) name of Butriptylene.

What drug class is Butriptylene in?

Butriptylene belongs to the butriptyline class. See all butriptyline drugs at /class/butriptyline.

What development phase is Butriptylene in?

Butriptylene is in Phase 2.

What does Butriptylene target?

Butriptylene targets Sodium-dependent serotonin transporter and is a butriptyline.

Drug class: All butriptyline drugs
Target: All drugs targeting Sodium-dependent serotonin transporter
Therapeutic area: All drugs in Neuroscience
Indication: Drugs for Depressive disorder

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