Serdexmethylphenidate

Azstarys (serdexmethylphenidate) is a small molecule pharmaceutical. Serdexmethylphenidate was first approved as Azstarys on 2021-05-07. It is used to treat attention deficit disorder with hyperactivity in the USA.

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FDA Novel Drug Approvals 2021

Events Timeline

Commercial

Clinical

Drug

Target

Variants

Financial

Trends

Safety

Events Timeline

YTD

Max

Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

Primary completion date

Completion date

Results first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
mental disorders	D001523

Trade Name

FDA

EMA

Combinations

Azstarys

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Dexmethylphenidate hydrochloride

Serdexmethylphenidate chloride

Tradename	Company	Number	Date	Products
AZSTARYS	Commave Therapeutics	N-212994 RX	2021-05-07	3 products, RLD, RS

Labels

FDA

EMA

Brand Name	Status	Last Update
azstarys	New Drug Application	2023-10-18

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
attention deficit disorder with hyperactivity	EFO_0003888	D001289	F90

Agency Specific

FDA

EMA

Expiration	Code
DEXMETHYLPHENIDATE HYDROCHLORIDE / SERDEXMETHYLPHENIDATE CHLORIDE, AZSTARYS, COMMAVE THERAP
2026-05-07	NCE

Patent Expiration

Patent	Expires	Flag	FDA Information
Dexmethylphenidate Hydrochloride / Serdexmethylphenidate Chloride, Azstarys, Commave Therap
10584112	2037-12-09	DS, DP
10584113	2037-12-09	DP
10759778	2037-12-09	DP
10858341	2037-12-09		U-3094
10954213	2037-12-09		U-3094
9079928	2032-07-27	DP

ATC Codes

N: Nervous system drugs

— N06: Psychoanaleptics

— N06B: Psychostimulants, agents used for adhd and nootropics

— N06BA: Centrally acting sympathomimetics

— N06BA15: Dexmethylphenidate and serdexmethylphenidate

HCPCS

No data

Clinical

Clinical Trials

8 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Attention deficit disorder with hyperactivity	D001289	EFO_0003888	F90	—	—	—	3	—	3
Hyperkinesis	D006948	HP_0000752	—	—	—	—	2	—	2
Autistic disorder	D001321	HP_0000717	F84.0	—	—	—	1	—	1
Autism spectrum disorder	D000067877	HP_0000729	F84.0	—	—	—	1	—	1
Pervasive child development disorders	D002659	EFO_0003756	F84	—	—	—	1	—	1

Indications Phases 3

No data

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Idiopathic hypersomnia	D020177	—	G47.11	—	1	—	—	—	1
Disorders of excessive somnolence	D006970	—	G47.1	—	1	—	—	—	1

Indications Phases 1

No data

Indications Without Phase

No data

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Serdexmethylphenidate
INN	serdexmethylphenidate
Description	Serdexmethylphenidate is a prodrug of dexmethylphenidate created by the pharmaceutical company KemPharm. The compound was first approved by the FDA as one of the active ingredients in Azstarys for the treatment of attention deficit hyperactivity disorder (ADHD) in children, adolescents, and adults in March 2021. Serdexmethylphenidate is a prodrug which has a delayed onset of action and a prolonged duration of effects compared to dexmethylphenidate, its parent compound.
Classification	Small molecule
Drug class	-
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	COC(=O)[C@H](c1ccccc1)[C@H]1CCCCN1C(=O)OC[n+]1cccc(C(=O)N[C@@H](CO)C(=O)O)c1