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NCE-1 Intelligence & Market Opportunity

Azstarys

Serdexmethylphenidate And dexmethylphenidate
CNS stimulant
Oral Capsule

Stimulant therapy for ADHD depends heavily on how quickly a dose takes effect and how long it lasts. Azstarys (serdexmethylphenidate and dexmethylphenidate) approached that problem through prodrug chemistry.

The capsule combines immediate-release dexmethylphenidate with serdexmethylphenidate, a prodrug converted to active drug in the lower gastrointestinal tract, delivering early onset from one component and extended coverage from the other. It is taken once daily for ADHD in patients 6 years and older.

Azstarys remains marketed as a Schedule II controlled substance without generic competition. Its prodrug design is the main differentiator in a mature methylphenidate market, making it relevant to tracking duration-focused and abuse-deterrent ADHD formulations.

Approval Date
03-Feb-21
NCE-1 Date
03-Feb-25
NCE Date
03-Feb-26
Commercial snapshot

Market performance & projections

Revenue ($M)
5
CAGR (%)
153.04%
Projected sales, 2026–2032 ($M)
Analyst projection, $M per year
2026
65
2027
132
2028
168
2029
205
2030
240
2031
276
2032
312
Molecule profile

Details & specifications

Molecule
Serdexmethylphenidate And dexmethylphenidate
Innovator
COMMAVE SUB, LLC
Dosage Form
Oral Capsule
Strength
EQ 7.8 mg base, EQ 10.4 mg base, EQ 5.2 mg base
Therapeutic Category
CNS stimulant
Usage
To treat attention deficit hyperactivity disorder
Good to know

Frequently asked questions

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