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 + Placebo

Phase 3Active

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Hype Score

Development Stage

✓

Pre-clinical

✓

Phase 1

✓

Phase 2

Phase 3

Approved

Indication / Disease

ADHD

Conditions

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

Trial Timeline

Jul 31, 2023 → Mar 1, 2026

NCT ID

NCT05924594

About 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 + Placebo

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 + Placebo is a phase 3 stage product being developed by Cingulate for ADHD. The current trial status is active. This product is registered under clinical trial identifier NCT05924594. Target conditions include ADHD, ADHD - Combined Type, Attention Deficit Hyper Activity.

Hype Score Breakdown

Clinical

Activity

Company

Novelty

Community

Clinical Trials (1)

NCT ID	Phase	Status	Start	Completion	Indication
NCT05924594	Phase 3	Active	Jul 31, 2023	Mar 1, 2026	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 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) + 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