serdexmethylphenidate
Trade name: AZSTARYS
Small moleculeapproved
Approved
Mar 2, 2021
Clinical trial activity
7 trials · 13 clinical orgs · 1 marketing orgs
Phase 1
0
Phase 2
4
Phase 3
3
Phase 4
3
Earliest trial started Dec 20, 2017 (NCT03292952)
Timeline
2010s
- Jan 1, 2017
Earliest Phase 3 Sponsor(trial)
2020s
- Mar 2, 2021
Boston Pharmaceuticals — Earliest FDA Approval
- Mar 2, 2021
Boston Pharmaceuticals — NDA Secondary Org
- Mar 2, 2021
Boston Pharmaceuticals — NDA Organization
- Jan 1, 2022
Earliest Phase 2 Sponsor(trial)
Indications
Mechanism of action
- Dopamine transporterANTAGONIST
SLC6A3 antagonist
- Norepinephrine transporterINHIBITOR
Norepinephrine transporter inhibitor
- Dopamine transporterINHIBITOR
Dopamine transporter inhibitor
Combination products
azstarys
with dexmethylphenidate
Also known as ak0901, serdexmethylphenidate and dexmethylphenidate
Approval history
- approvedMar 2, 2021
Chemistry & pharmacology
Loading structure…
SMILES
COC(=O)[C@H](c1ccccc1)[C@H]1CCCCN1C(=O)OC[n+]1cccc(C(=O)N[C@@H](CO)C(=O)O)c1.[Cl-]- Mol. weight
- 535.98 g/mol
- Lipinski Ro5
- 1 violation(s)
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Prodrug
Sources
- ChEMBLCHEMBL4301162 ↗
- ChEMBLCHEMBL4298139 ↗
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06359899 | Phase 3 | May 31, 2024 | Ark Biosciences Inc. |
| NCT06000501 | Phase 4 | Sep 14, 2023 | Corium International Inc., New York University |
| NCT05721235 | Phase 4 | May 24, 2023 | Almac Clinical Services LLC, Center for Psychiatry And Behavioral Medicine Inc., Corium International Inc., Premier Research Group, Prometrika, LLC, Worldwide Clinical Trials |
| NCT05685732 | Phase 4 | Mar 22, 2023 | Almac Clinical Services LLC, Center for Psychiatry And Behavioral Medicine Inc., Corium International Inc., Premier Research Group, Prometrika, LLC |
| NCT05668754 | Phase 2 | Dec 22, 2022 | Rho, Inc., Sheffield Hallam University, Zevra Therapeutics |
| NCT03460652 | Phase 3 | Mar 13, 2018 | Center for Psychiatry And Behavioral Medicine Inc., KemPharm, Inc. |
| NCT03292952 | Phase 3 | Dec 20, 2017 | Duke University, KemPharm, Inc. |
Showing 7 of 7 trials
Page 1 / 1
Organizations
Research & Development (13)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Center for Psychiatry And Behavioral Medicine Inc. | Academic/Hospital | 3 | 0 | 2 | 2018 |
| Corium International Inc. | For profit | 3 | 2 | 1 | 2023 |
| Almac Clinical Services LLC | For profit | 2 | 0 | 1 | 2023 |
| KemPharm, Inc. | For profit | 2 | 2 | 1 | 2017 |
| Premier Research Group | For profit | 2 | 0 | 1 | 2023 |
| Prometrika, LLC | For profit | 2 | 0 | 1 | 2023 |
| Ark Biosciences Inc. | For profit | 1 | 1 | 1 | 2024 |
| Duke University | Academic/Hospital | 1 | 0 | 1 | 2017 |
| New York University | Academic/Hospital | 1 | 1 | 1 | 2023 |
| Rho, Inc. | For profit | 1 | 0 | 1 | 2022 |
| Sheffield Hallam University | Academic/Hospital | 1 | 0 | 1 | 2022 |
| Worldwide Clinical Trials | For profit | 1 | 0 | 1 | 2023 |
| Zevra Therapeutics | For profit | 1 | 1 | 1 | 2022 |
13 organizations
Page 1 / 1
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Boston Pharmaceuticals | For profit | NDA2 | Mar 2, 2021 |
| Boston Pharmaceuticals | For profit | NDA | Mar 2, 2021 |