Dexpramipexole

Summary

Dexpramipexole (CHEMBL249420) is a phase-3 clinical-stage small molecule; indicated across 3 conditions including amyotrophic lateral sclerosis and hypereosinophilic syndrome.

At a glance

• Status: Max clinical phase 3 (not approved)
• Modality: Small molecule
• Indications: 3 conditions
• Clinical trials: 84
• Chemistry: 211.33 Da · C10H17N3S

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL249420
Name	Dexpramipexole
Type	Small molecule
Max phase	3
FDA approved	no
PubChem CID	59868
Molecular formula	C10H17N3S
Molecular weight	211.33
InChIKey	FASDKYOPVNHBLU-SSDOTTSWSA-N

SMILES: CCCN[C@@H]1CCC2=C(C1)SC(=N2)N

IUPAC name: (6R)-6-N-propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine

Also known as: (r)-pramipexole, Dexpramipexol, Dexpramipexole, DEXPRAMIPEXOLE, (+)-R-Pramipexole dihydrochloride, Pramipexole

Parent form; salt/anhydrous children: CHEMBL2105687, CHEMBL3216394

Patent coverage: 2,500 distinct patent families (8,898 SureChEMBL compound mentions), from 1 matched compound structure(s). Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

Broader ChEMBL bioactivity targets: 3 (assay-derived). Sample: Histamine H2 receptor, D(2) dopamine receptor, D(3) dopamine receptor.

Bioactivity

ChEMBL activities: 3 potent at pChembl ≥ 5 of 5 total. Top 30 by potency (10 = 0.1 nM, 6 = 1 µM):

Target	pChembl	Type	Value	Unit	Activity ID
DRD3	9.18	Ki	0.66	nM	CHEMBL_ACT_23175813
DRD2	6	Ki	1000	nM	CHEMBL_ACT_23175794
HRH2	5.07	EC50	8511	nM	CHEMBL_ACT_23175688

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
amyotrophic lateral sclerosis	3	MONDO:0004976	MONDO:0004976
hypereosinophilic syndrome	2	MONDO:0015691	EFO:1001467
asthma	2	MONDO:0004979	MONDO:0004979

Clinical trials

Total trials: 84.

Phase distribution

Phase	Trials
PHASE4	22
PHASE3	20
Not specified	14
PHASE2	13
PHASE1	11
EARLY_PHASE1	2
PHASE2/PHASE3	1
PHASE1/PHASE2	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT05003648	PHASE4	ACTIVE_NOT_RECRUITING	Treating Leg Symptoms in Women With X-linked Adrenoleukodystrophy
NCT06580041	PHASE4	ENROLLING_BY_INVITATION	Precision Care for Major Depressive Disorder
NCT00102856	PHASE4	SUSPENDED	Neuromodulation and Language Acquisition (Stage Ib)
NCT00231959	PHASE4	COMPLETED	Effectiveness of Pramipexole for Treatment-Resistant Depression
NCT00297778	PHASE4	COMPLETED	Pramipexole Versus Placebo in Parkinson’s Disease (PD) Patients With Depressive Symptoms
NCT00321854	PHASE4	COMPLETED	Study of (Mirapex) Pramipexole for the Early Treatment of Parkinsons Disease (PD)
NCT00344994	PHASE4	COMPLETED	SWITCH:Restless Legs Patients Switched to Ropinirole From Pramipexole
NCT00349531	PHASE4	COMPLETED	A Phase IV Trial With Pramipexole to Investigate the Effects on RLS Symptoms and Sleep Disturbance in Patients With RLS
NCT00356096	PHASE4	COMPLETED	Phase IV Trial With Pramipexole to Evaluate Safety and Efficacy in Patients With RLS Associated With Mood Disturbances
NCT00375284	PHASE4	COMPLETED	A 6 Week Trial to Study the Efficacy and Safety of a Starting Dose 0.25 mg Pramipexole (Mirapex) in Patients With RLS
NCT00402233	PHASE4	COMPLETED	A Randomized, Double-blind, Active (Pramipexole 0.5 mg Tid) and Placebo Controlled, Study of Pramipexole Given 0.5 mg and 0.75 mg Bid Over 12-week Treatment in Early Parkinson’s Disease (PD) Patients
NCT00472199	PHASE4	COMPLETED	Long-term Efficacy, Safety and Tolerability of Pramipexole in Patients With Idiopathic Moderate to Severe Restless Legs Syndrome (RLS)
NCT00597896	PHASE4	COMPLETED	Cognitive Enhancement in Bipolar Disorder
NCT01048229	PHASE4	TERMINATED	Evaluation of the Tolerance and Acceptability of Rasagiline in the Treatment of Early-stage Parkinson’s Disease
NCT01066897	PHASE4	TERMINATED	Imaging the Nucleus Accumbens in Major Depressed Patients ‘Treated With Pramipexole
NCT01673724	PHASE4	COMPLETED	Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson’s Disease
NCT02025608	PHASE4	COMPLETED	Autonomic Function and Cardiovascular Risk in Restless Legs Syndrome
NCT02033369	PHASE4	COMPLETED	Imaging Dopamine Release in Depression
NCT02233023	PHASE4	COMPLETED	Ophthalmologic Safety of Long Term Treatment With Pramipexole Compared to Bromocriptine or Other Dopamine Agonists in Patients With Parkinson’s Disease
NCT02397837	PHASE4	COMPLETED	Targeting Cognition in Bipolar Disorder With Pramipexole
NCT03817554	PHASE4	TERMINATED	Pramipexole for Restless Leg Syndrome in Peritoneal Dialysis Patients
NCT04936126	PHASE4	UNKNOWN	Comparison of Antidepressant Augmentation With Amantadine vs Pramipexole vs Quetiapine in Treatment Resistant Depression
NCT00133198	PHASE3	COMPLETED	Efficacy and Safety of Pramipexole Compared to Placebo in the Treatment of Restless Legs Syndrome (RLS)
NCT00144209	PHASE3	COMPLETED	Assess Efficacy and Safety of the Dopamine Agonist Pramipexole Versus Levodopa / Benserazide (Madopar® DR) in Patients With Restless Legs Syndrome
NCT00152958	PHASE3	COMPLETED	A Study in Patients Suffering From Idiopathic Restless Legs Syndrome Who Responded to a Preceding, 6-month Treatment With Open-label Pramipexole Including Titration (0.125, 0.25, 0.5, 0.75 mg Orally q.n.)
NCT00240409	PHASE3	COMPLETED	Randomized Single-blind Placebo Controlled Comparative Trial of Pramipexole and Bromocriptine in Parkinson’s Disease
NCT00275457	PHASE3	COMPLETED	Efficacy and Safety of Pramipexole (PPX) in Moderate to Severe Idiopathic Restless Legs Syndrome (RLS) Patients
NCT00335166	PHASE3	COMPLETED	SLV 308 and Pramipexole for Treatment of Patients With Early Parkinson Disease
NCT00577460	PHASE3	COMPLETED	Long-term Safety Study of Open-label Pramipexole ER in Patients With Advanced PD
NCT00601523	PHASE3	COMPLETED	Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD).
NCT00654498	PHASE3	COMPLETED	Pramipexole in Out-patients With Idiopathic Restless Legs Syndrome (IRLS)
NCT00991276	PHASE3	COMPLETED	Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance
NCT01106053	PHASE3	WITHDRAWN	Pramipexole for Binge Eating Disorder
NCT01281189	PHASE3	COMPLETED	Phase 3 Study of Dexpramipexole in ALS
NCT01320982	PHASE3	UNKNOWN	Minocycline, Acetylsalicylic Acid or Pramipexole vs Placebo in Patients With Schizophrenia or Schizoaffective Disorder
NCT01441284	PHASE3	WITHDRAWN	Efficacy of Pramipexole Extended Release in the Treatment of Essential Tremor
NCT01622088	PHASE3	TERMINATED	Phase 3 Extension Study of Dexpramipexole in ALS
NCT02172573	PHASE3	COMPLETED	Safety and Efficacy of Pramipexole and Bromocriptine Combined With L-dopa in Parkinson’s Disease
NCT02177357	PHASE3	COMPLETED	Pramipexole in Untreated and Levodopa-treated Parkinson’s Disease Patients
NCT03329508	PHASE3	COMPLETED	A Phase 3 Study With P2B001 in Subjects With Early Parkinson’s

Clinical evidence (CIViC)

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

Pharmacology

Pharmacogenomics

No CPIC/DPWG dosing guideline, but PharmGKB curates 1 clinical and 1 variant annotation(s) for this drug (gene-keyed; see PharmGKB).

Related molecules

Related molecules

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