Last reviewed 2026-05-21 · How we verify

Tecipul (SETIPTILINE)

Phase 2 active Small molecule ✓ Verified May 2026 Quality 15/100

Tecipul (generic name: SETIPTILINE) is a drug. It is currently in Phase 2 development for Depressive disorder.

Tecipul is thought to work by modulating neurotransmitter activity in the brain.

Tecipul is a small molecule with the synonyms ORG 8282, SETIPTILINA, and SETIPTILINE.

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	SETIPTILINE
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

In simple terms, Tecipul is believed to help regulate the levels and activity of certain chemicals in the brain, such as serotonin and norepinephrine, which play a crucial role in mood regulation and emotional response.

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:

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

Frequently asked questions about Tecipul

What is Tecipul?

Tecipul (SETIPTILINE) is a Small molecule drug, indicated for Depressive disorder.

How does Tecipul work?

Tecipul is thought to work by modulating neurotransmitter activity in the brain.

What is Tecipul used for?

Tecipul is indicated for Depressive disorder.

What is the generic name of Tecipul?

SETIPTILINE is the generic (nonproprietary) name of Tecipul.

What development phase is Tecipul in?

Tecipul is in Phase 2.

Therapeutic area: All drugs in Neuroscience
Indication: Drugs for Depressive disorder

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