Esmirtazapine

Summary

Esmirtazapine (CHEMBL1366933) is a phase-3 clinical-stage small molecule; indicated across 1 condition including insomnia.

At a glance

• Status: Max clinical phase 3 (not approved)
• Modality: Small molecule
• Indications: 1 condition
• Clinical trials: 8
• Chemistry: 265.35 Da · C17H19N3

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL1366933
Name	Esmirtazapine
Type	Small molecule
Max phase	3
FDA approved	no
PubChem CID	3085218
Molecular formula	C17H19N3
Molecular weight	265.35
InChIKey	RONZAEMNMFQXRA-MRXNPFEDSA-N

SMILES: CN1CCN2[C@H](C1)C3=CC=CC=C3CC4=C2N=CC=C4

IUPAC name: (7S)-5-methyl-2,5,19-triazatetracyclo[13.4.0.02,7.08,13]nonadeca-1(15),8,10,12,16,18-hexaene

Also known as: (s)-mirtazapine, (s)-org 3770, Esmirtazapina, Esmirtazapine, Mirtazapine, (s)-, ESMIRTAZAPINE

Parent form; salt/anhydrous children: CHEMBL2107339

Patent coverage: 1,530 distinct patent families (5,642 SureChEMBL compound mentions), from 2 matched compound structure(s). One matched structure accounts for 5,631 (100%) of the total. Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

1 indication (0 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
insomnia	3	MONDO:0013600	EFO:0004698

Clinical trials

Total trials: 8.

Phase distribution

Phase	Trials
PHASE3	8

Top trials by phase / activity

NCT	Phase	Status	Title
NCT00482612	PHASE3	COMPLETED	Study of the Safety and Effectiveness of Esmirtazapine in Participants With Chronic Primary Insomnia (P05706)
NCT00506389	PHASE3	COMPLETED	A Six Week, Double-Blind Randomized, Efficacy and Safety, Sleep Lab Trial With Esmirtazapine (Org 50081) (P05707)
NCT00535288	PHASE3	COMPLETED	Dose-Finding Safety and Efficacy Trial of Org 50081 (Esmirtazapine) in the Treatment of Vasomotor Symptoms (177001/P06472/MK-8265-013)
NCT00560833	PHASE3	COMPLETED	Dose-Finding Safety and Efficacy Trial of Org50081 (Esmirtazapine) in the Treatment of Vasomotor Symptoms (46101/P06459/MK-8265-012)
NCT00561574	PHASE3	COMPLETED	A Long-Term Safety Study of Org 50081 (Esmirtazapine) in Elderly Outpatients With Chronic Primary Insomnia (176005/P05697/MK-8265-001)
NCT00561821	PHASE3	COMPLETED	Efficacy and Safety Study of Org 50081 (Esmirtazapine) in Elderly Participants (P05709)
NCT00631657	PHASE3	COMPLETED	A 6-Month Efficacy and Safety Study of Org 50081 in Adult Patients With Chronic Primary Insomnia (21106/P05701/MK-8265-002)
NCT00750919	PHASE3	TERMINATED	Twenty-six Week Extension Trial of Org 50081 (Esmirtazapine) in Outpatients With Chronic Primary Insomnia (176003/P05721/MK-8265-007)

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).