Drugs / Dextroamphetamine
Dextroamphetamine
also known as
d-Amphetamine · Dexedrine · d-amphetamine sulfate · dexamfetamine · Dexamphetamine · Dextroamphetamine Sulfate · Amfe-dyn · Amfetamine, (s)- · +31 more
Small molecule targets SLC18A2, SLC6A2, SLC6A3 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed attention deficit-hyperactivity disorder 1 milestone | |||||
| Filed | US (FDA) | — | attention deficit-hyperactivity disorder | 2021-02-22 | “NOVEN SUBMITS NEW DRUG APPLICATION FOR INVESTIGATIONAL DEXTROAMPHETAMINE TRANSDERMAL SYSTEM FOR ADHD” noven.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | ADDERALL 5 | — | 1960-01-19 | fda.gov ↗ |
Trials 37
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News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2022-03-23 | Noven Therapeutics | Regulatory FDA Approves Once-Daily XELSTRYM™ (dextroamphetamine) Transdermal System, CII, for the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Adults and Pediatric Patients 6 Years and Older noven.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has approved XELSTRYM™ (dextroamphetamine) transdermal system, CII, for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) for adults and pediatric patients 6 years and older. |
| 2021-04-27 | Noven Therapeutics | Results Noven to Present Pivotal Study Results For Investigational Dextroamphetamine Transdermal System For Pediatric ADHD Patients noven.com ↗
The initial onset of ATS efficacy was observed at 2 hours post-dose and continued through all post-dose time-points up to 12 hours post-dose. |
| 2021-02-22 | Noven Therapeutics | Regulatory Noven Submits New Drug Application for Investigational Dextroamphetamine Transdermal System for ADHD noven.com ↗
Noven Pharmaceuticals, Inc., (“Noven”) a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., today confirmed it has submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its dextroamphetamine transdermal system (“ATS”). |
| 2013-07-22 | Noven Therapeutics | Results Noven Announces Positive Phase 2 Results of Investigational d-Amphetamine Transdermal System For ADHD noven.com ↗ |
All press releases naming this drug 8 releases
Evidence & citations 47 cited values
Every value below carries the sentence it was read from. 61 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Dextroamphetamine | “Objectives: To assess efficacy and safety of the new Dextroamphetamine Transdermal System (d-ATS) to treat children and adolescents (aged 6-17 years) with...” PMID 35020462 ↗ Jan 202222“The purpose of this study is to determine if administration of dextroamphetamine (amph) linked with customarily used Rehabilitation Medicine accelerates motor recovery after stroke.” NCT00001783 ↗ “Sequential Tranylcypromine (TC), TC + Dextroamphetamine and TC + Triiodothyronine for Refractory Depression” NCT00296686 ↗ “Stimulant medication standard in the care of ADHD, such as methylphenidate or dextroamphetamine” NCT00794625 ↗ “Dextroamphetamine” NCT00573859 ↗ “Dextroamphetamine” NCT01399827 ↗ |
| Known as | Amfe-dyn | ChEMBL registry synonym — accepted as the source's own label CHEMBL612 ↗ |
| Known as | Amfetamine, (s)- | ChEMBL registry synonym — accepted as the source's own label CHEMBL612 ↗ |
| Known as | amph | “The purpose of this study is to determine if administration of dextroamphetamine (amph) linked with customarily used Rehabilitation Medicine accelerates motor recovery after stroke.” NCT00001783 ↗ |
| Known as | Bar-dex | ChEMBL registry synonym — accepted as the source's own label CHEMBL612 ↗ |
| Known as | d-amph | “BRS function was probed in 20 AD patients using dextroamphetamine (d-amph) challenge.” PMID 18591575 ↗ Jul 2008 |
| Known as | d-Amphetamine | “The study hypothesis is that dextro-amphetamine (d-amphetamine) will be safe and effective when used to augment treatment for Obsessive-Compulsive Disorder (OCD)” NCT00363298 ↗20“Two stimulant medications, modafinil and d-amphetamine, when tested individually, have shown safety and efficacy for treatment of cocaine addiction.” PMID 22969732 ↗ Aug 2012 “Stimulants: d-amphetamine, caffeine, ephedrine, methylphenidate, diethylproprion” NCT02033707 ↗ “Irritation and Sensitization Study of d-Amphetamine Transdermal System” NCT04094025 ↗ “20 mg/70 kg (20 mg maximum) dose of d-amphetamine will be measured” NCT00611936 ↗ “d-Amphetamine: 40.3mg p.o, single dose” NCT02668926 ↗ |
| Known as | D-amphetamine hemisulfate salt | ChEMBL registry synonym — accepted as the source's own label CHEMBL612 ↗ |
| Known as | d-amphetamine sulfate | “d-amphetamine sulfate capsules, 30 mg, CII (25% SR, 30% pH coat, slow release; formulation B)” NCT01886469 ↗ |
| Known as | d-ATS | “Objectives: To assess efficacy and safety of the new Dextroamphetamine Transdermal System (d-ATS) to treat children and adolescents (aged 6-17 years) with...” PMID 35020462 ↗ Jan 2022 |
| Known as | Depalone | ChEMBL registry synonym — accepted as the source's own label CHEMBL612 ↗ |
| Known as | dexamfetamine | “There is evidence that stimulants such as dexamfetamine and methylphenidate lead to an improvement in sustained focused attention, working memory, and a variety of cognitive...” NCT06967857 ↗ |
| Known as | Dexamfetamine phosphate | ChEMBL registry synonym — accepted as the source's own label CHEMBL612 ↗ |
| Known as | Dexamfetamine sulfate | ChEMBL registry synonym — accepted as the source's own label CHEMBL612 ↗ |
| Known as | Dexamfetamine sulphate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02363075 ↗ |
| Known as | Dexampex | ChEMBL registry synonym — accepted as the source's own label CHEMBL612 ↗ |
| Known as | Dexamphetamine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02768441 ↗ |
| Known as | Dexamphetamine sulfate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04968522 ↗ |
| Known as | Dexamphetamine sulphate | ChEMBL registry synonym — accepted as the source's own label CHEMBL612 ↗ |
| Known as | Dexanfetamina | ChEMBL registry synonym — accepted as the source's own label CHEMBL612 ↗ |
| Known as | Dexedrine | “patient will continue to take stable dosage of usual stimulant therapy (Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine)” NCT01985581 ↗8“Dextroamphetamine (Dexedrine), gel-capsule, 20mg, single-dose, 1-day” NCT01577706 ↗ “Dexedrine (0-60 mg/day); Strattera (0-80 mg/day)” NCT00697138 ↗ “Dexedrine” NCT02210728 ↗ “Dexedrine” NCT02204410 ↗ “Dexedrine” NCT02142140 ↗ “Dexedrine” NCT02566824 ↗ |
| Known as | Dexedrine spansule | ChEMBL registry synonym — accepted as the source's own label CHEMBL612 ↗ |
| Known as | Dexedrine Spansules | “d-Amphetamine sustained release (SR) (Dexedrine Spansules) started at 15 mg (day 1-2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid...” NCT00218062 ↗ |
| Known as | Dexidrine | ChEMBL registry synonym — accepted as the source's own label CHEMBL612 ↗ |
| Known as | Dextroamphetamine adipate component of delcobese | ChEMBL registry synonym — accepted as the source's own label CHEMBL612 ↗ |
| Known as | DEXTROAMPHETAMINE PHOSPHATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL612 ↗ |
| Known as | Dextroamphetamine resin complex | ChEMBL registry synonym — accepted as the source's own label CHEMBL612 ↗ |
| Known as | Dextroamphetamine saccharate component of mydayis | ChEMBL registry synonym — accepted as the source's own label CHEMBL612 ↗ |
| Known as | Dextroamphetamine Sulfate | “Dextroamphetamine Sulfate From an Abuse-Deterrent Immediate-Release Formulation (ADAIR)” NCT04232644 ↗ |
| Known as | Dextroamphetamine sulfate cii | ChEMBL registry synonym — accepted as the source's own label CHEMBL612 ↗ |
| Known as | Dextroamphetamine sulfate component of delcobese | ChEMBL registry synonym — accepted as the source's own label CHEMBL612 ↗ |
| Known as | Dextroamphetamine sulfate component of mydayis | ChEMBL registry synonym — accepted as the source's own label CHEMBL612 ↗ |
| Known as | Dextroamphetamine sulphate | ChEMBL registry synonym — accepted as the source's own label CHEMBL612 ↗ |
| Known as | Dextrostat | ChEMBL registry synonym — accepted as the source's own label CHEMBL612 ↗ |
| Known as | Ferndex | ChEMBL registry synonym — accepted as the source's own label CHEMBL612 ↗ |
| Known as | NSC-27104 | ChEMBL registry synonym — accepted as the source's own label CHEMBL612 ↗ |
| Known as | NSC-73713 | ChEMBL registry synonym — accepted as the source's own label CHEMBL612 ↗ |
| Known as | SR-Dexamphetamine | “After 24 weeks patients will be randomized to either (double-blind) continuation or discontinuation (placebo) of SR-Dexamphetamine treatment to assess the consequences of...” NCT05529927 ↗ |
| Known as | Sustained-release Dexamphetamine | “Drug: Sustained-release Dexamphetamine” NCT05529927 ↗ |
| Known as | Xelstrym | ChEMBL registry synonym — accepted as the source's own label CHEMBL612 ↗ |
| Action | Activate | “used to stimulate dopamine release in the brain” NCT03349606 ↗ |
| Action | Inhibit | “Synaptic vesicular amine transporter inhibitor” CHEMBL612 ↗ |
| Modality | Small molecule | — CHEMBL612 ↗ |
| Route | Oral | “oral amphetamine” NCT00611936 ↗ |
| Target | SLC18A2 | “Synaptic vesicular amine transporter inhibitor” CHEMBL612 ↗ |
| Target | SLC6A2 | “Norepinephrine transporter releasing agent” CHEMBL612 ↗ |
| Target | SLC6A3 | “Dopamine transporter releasing agent” CHEMBL612 ↗ |