CTx-1301-Dexmethylphenidate 12.5 mg (titration only) + CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose) + CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose) + CTx-1301-Dexmethylphenidate 37.5 mg (randomized fixed dose) + Placebo

Phase 3Completed

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Hype Score

Development Stage

✓

Pre-clinical

✓

Phase 1

✓

Phase 2

Phase 3

Approved

Indication / Disease

ADHD

Conditions

ADHD, Attention Deficit Hyperactivity Disorder, ADHD - Combined Type, Attention Deficit Hyperactivity Disorder Combined, Attention-deficit Hyperactivity, Attention Deficit Hyper Activity

Trial Timeline

Aug 1, 2023 → Feb 29, 2024

NCT ID

NCT05286762

About CTx-1301-Dexmethylphenidate 12.5 mg (titration only) + CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose) + CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose) + CTx-1301-Dexmethylphenidate 37.5 mg (randomized fixed dose) + Placebo

CTx-1301-Dexmethylphenidate 12.5 mg (titration only) + CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose) + CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose) + CTx-1301-Dexmethylphenidate 37.5 mg (randomized fixed dose) + Placebo is a phase 3 stage product being developed by Cingulate for ADHD. The current trial status is completed. This product is registered under clinical trial identifier NCT05286762. Target conditions include ADHD, Attention Deficit Hyperactivity Disorder, ADHD - Combined Type.

Hype Score Breakdown

Clinical

Activity

Company

Novelty

Community

Clinical Trials (1)

NCT ID	Phase	Status	Start	Completion	Indication
NCT05286762	Phase 3	Completed	Aug 1, 2023	Feb 29, 2024	ADHD

Competing Products

20 competing products in ADHD

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Product	Company	Stage	Hype Score
atomoxetine	Eli Lilly	Approved	85
Strattera (atomoxetine)	Eli Lilly	Approved	85
Atomoxetine + placebo	Eli Lilly	Approved	85
Atomoxetine Hydrochloride + placebo	Eli Lilly	Approved	85
atomoxetine (Strattera)	Eli Lilly	Approved	85
Atomoxetine + stimulants (any approved ADHD medication)	Eli Lilly	Pre-clinical	23
dasotraline + Placebo	Sumitomo Pharma	Phase 3	77
dasotraline	Sumitomo Pharma	Phase 1	33
dasotraline 4mg	Sumitomo Pharma	Phase 3	77
AZD1446 + AZD1446 + AZD1446 + Placebo	AstraZeneca	Phase 2	52
Placebo + AZD3480 + AZD3480	AstraZeneca	Phase 2	52
MK0249 + Concerta (methylphenidate) + Placebo	Merck	Phase 2	52
Focalin XR	Novartis	Phase 3	77
Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR) + Placebo	Novartis	Approved	85
Dexmethylphenidate HCl extended-release capsules	Novartis	Phase 3	77
Methylphenidate hydrochloride	Novartis	Phase 3	77
Focalin XR	Novartis	Phase 3	77
methylphenidate HCl ERCT + Placebo	Pfizer	Approved	84
methylphenidate HCl ERCT	Pfizer	Approved	84
Very Low Dose Quillivant XR + Low Dose Quillivant XR + Moderate Dose Quillivant XR	Pfizer	Approved	84

Other Products from Cingulate

CTx-1301 - Dexmethylphenidate 6.25mg + CTx-1301 - Dexmethylphenidate 12.5mg + CTx-1301 - Dexmethylphenidate 18.75mg + CTx-1301 - Dexmethylphenidate 25.0mg + CTx-1301 - Dexmethylphenidate 31.25mg + CTx-1301 - Dexmethylphenidate 37.5mg + PlaceboPhase 3

CTx-1301 - Dexmethylphenidate 25mg + CTx-1301 - Dexmethylphenidate 37.5mg + CTx-1301 - Dexmethylphenidate 50mg + PlaceboPhase 3

Dexmethylphenidate 5 Mg Oral Capsule, Extended Release + Dexmethylphenidate 6.25 mg Tablet + Dexmethylphenidate 40 Mg Oral Capsule, Extended Release + Dexmethylphenidate 50 mg TabletPhase 1/2

DexmethylphenidatePhase 1