Dasotraline

Summary

Dasotraline (CHEMBL3301595) is a phase-3 clinical-stage small molecule; indicated across 3 conditions including attention deficit-hyperactivity disorder and eating disorder.

At a glance

• Status: Max clinical phase 3 (not approved)
• Modality: Small molecule
• Indications: 3 conditions
• Clinical trials: 12
• Chemistry: 292.2 Da · C16H15Cl2N

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL3301595
Name	Dasotraline
Type	Small molecule
Max phase	3
FDA approved	no
PubChem CID	9947999
Molecular formula	C16H15Cl2N
Molecular weight	292.2
InChIKey	SRPXSILJHWNFMK-MEDUHNTESA-N

SMILES: C1C[C@H](C2=CC=CC=C2[C@@H]1C3=CC(=C(C=C3)Cl)Cl)N

IUPAC name: (1R,4S)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydronaphthalen-1-amine

Also known as: (1r,4s)-trans-norsertraline, Dasotralina, Dasotraline, Norsertraline, (1r,4s)-trans-, SEP-225289, DASOTRALINE, DASOTRALINE HYDROCHLORIDE

Parent form; salt/anhydrous children: CHEMBL3301596

Patent coverage: 45 distinct patent families (141 SureChEMBL compound mentions), from 2 matched compound structure(s). One matched structure accounts for 131 (93%) 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

3 indications (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
attention deficit-hyperactivity disorder	3	MONDO:0007743	EFO:0003888
eating disorder	3	MONDO:0005451	EFO:0005203
major depressive disorder	2	MONDO:0002009	MONDO:0002009

Clinical trials

Total trials: 12.

Phase distribution

Phase	Trials
PHASE3	7
PHASE2/PHASE3	2
PHASE2	2
PHASE1	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT02160262	PHASE3	COMPLETED	Open-label Safety Study in Adults With ADHD
NCT02276209	PHASE3	COMPLETED	Dasotraline Adult ADHD Study
NCT02428088	PHASE2/PHASE3	COMPLETED	Dasotraline Pediatric ADHD Study
NCT02457819	PHASE3	COMPLETED	Dasotraline Pediatric Extension Study
NCT02564588	PHASE2/PHASE3	COMPLETED	Dasotraline Binge Eating Disorder Study
NCT02684279	PHASE3	COMPLETED	Dasotraline Binge Eating Disorder Extension Study
NCT02734693	PHASE3	COMPLETED	A Study to Evaluate the Efficacy and Safety of Dasotraline in Children 6 to 12 Years of Age With Attention-Deficit Hyperactivity Disorder (ADHD) in a Simulated Classroom Setting.
NCT03107026	PHASE3	COMPLETED	A Study to Evaluate a Drug (Dasotraline) on the Safety, Effectiveness and How Well the Body Tolerates it, in Adults With Moderate to Severe Binge Eating Disorder
NCT03231800	PHASE3	COMPLETED	A Study to Evaluate the Efficacy and Safety of Dasotraline in Children 6 to 12 Years Old With Attention-Deficit Hyperactivity Disorder (ADHD) in a Simulated Classroom Setting.
NCT00584974	PHASE2	COMPLETED	A Safety, Efficacy and Tolerability Study of SEP-225289
NCT01692782	PHASE2	COMPLETED	Adult Attention Deficit Hyperactivity Disorder
NCT02795637	PHASE1	COMPLETED	Study of the What the Body Does to the Drug in Subjects With Mild, Moderate, and Severe Liver Dysfunction

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).