Molindone

also known as SPN-810 · EN-1733A · Moban · Molindona · Molindone hcl · Molindone Hydrochloride · Molindone Hydrochloride Extended-Release

Small molecule targets DRD2, HTR2A via inhibition

Developed for: attention deficit-hyperactivity disorder · disruptive behavior disorder · conduct disorder · impulse control disorder · schizophrenia
Investigated by: Supernus Pharmaceuticals, Inc.

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Approved	US (FDA)	MOBAN	—	1974-01-18	fda.gov ↗

Trials 7 · a red edge is where a trial was stopped

today

US approved 1974

NCT03597503 · Ph 3 NCT02691182 · Ph 3 NCT02618434 · Ph 3 NCT02618408 · Ph 3 NCT01416064 · Ph 2 NCT01364662 · Ph 2 NCT00626236 · Ph 2

19731974197519761977197819791980198119821983198419851986198719881989199019911992199319941995199619971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 23 trials
Phase 2	NCT01416064	Sep 2011 → Jan 2013	disruptive behavior disorder	Supernus Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 2	NCT01364662	Jun 2011 → Oct 2012	disruptive behavior disorder	Supernus Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 2	NCT00626236	Oct 2008 → Sep 2009	attention deficit-hyperactivity disorder, conduct disorder	Supernus Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 34 trials
Phase 3	NCT03597503	Jul 2018 → Jan 2020	attention deficit-hyperactivity disorder	Supernus Pharmaceuticals, Inc.	Terminated	No outcome recorded
Phase 3	NCT02691182	Apr 2016 → May 2021	attention deficit-hyperactivity disorder	Supernus Pharmaceuticals, Inc.	Terminated	No outcome recorded
Phase 3	NCT02618434	Feb 2016 → Nov 2019	attention deficit-hyperactivity disorder	Supernus Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 3	NCT02618408	Jan 2016 → Sep 2019	attention deficit-hyperactivity disorder	Supernus Pharmaceuticals, Inc.	Completed	No outcome recorded

Also used as a comparator or background therapy in 2 trials

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 21 trial
Phase 2	NCT03638466 Comparator	May → Nov 2019	attention deficit-hyperactivity disorder, impulse control disorder	Supernus Pharmaceuticals, Inc.	Terminated	No outcome recorded
Phase 41 trial
Phase 4	NCT00053703 Comparator	Feb 2002 → May 2007	schizophrenia	University of North Carolina, Chapel Hill	Completed	No outcome recorded

Evidence & citations 13 cited values

Every value below carries the sentence it was read from. 10 sources stand behind the page.

Field	Value	Cited text
Known as	Molindone	“Assessment of the Efficacy and Safety of Molindone Hydrochloride Extended-Release for the Treatment of Impulsive Aggression in Pediatric Patients With Attention...” NCT02618434 ↗ 2 NCT00053703 ↗ NCT01416064 ↗
Known as	EN-1733A	ChEMBL registry synonym — accepted as the source's own label CHEMBL460 ↗
Known as	Moban	ChEMBL registry synonym — accepted as the source's own label CHEMBL460 ↗
Known as	Molindona	ChEMBL registry synonym — accepted as the source's own label CHEMBL460 ↗
Known as	Molindone hcl	ChEMBL registry synonym — accepted as the source's own label CHEMBL460 ↗
Known as	Molindone Hydrochloride	“Assessment of the Efficacy and Safety of Molindone Hydrochloride Extended-Release for the Treatment of Impulsive Aggression in Pediatric Patients With Attention...” NCT02618408 ↗
Known as	Molindone Hydrochloride Extended-Release	“Assessment of the Efficacy and Safety of Molindone Hydrochloride Extended-Release for the Treatment of Impulsive Aggression in Pediatric Patients With Attention...” NCT02618434 ↗
Known as	SPN-810	ClinicalTrials.gov intervention name — accepted as the source's own label NCT03597503 ↗ 4 NCT00626236 ↗ NCT03638466 ↗ NCT02691182 ↗ NCT01364662 ↗
Action	Inhibit	“Serotonin 2a (5-HT2a) receptor antagonist” CHEMBL460 ↗ 1 “Dopamine D2 receptor antagonist” CHEMBL460 ↗
Modality	Small molecule	— CHEMBL460 ↗
Route	Oral	“oral molindone from 10-140mg/daily for up to 52 weeks” NCT00053703 ↗
Target	DRD2	“Dopamine D2 receptor antagonist” CHEMBL460 ↗
Target	HTR2A	“Serotonin 2a (5-HT2a) receptor antagonist” CHEMBL460 ↗