Wednesday, July 8, 2026

Drug profile · INN

guanfacine hydrochloride

guanfacine hydrochloride (INTUNIV PARTIAL CHANGE APPROVAL) is a adrenergic receptor alpha-2 agonist. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved PMDA: approved
US status approved
Patents linked 0
Pipeline programs 15
News articles 0
Drug details — guanfacine hydrochloride
US status
approved
Class
Route
ORAL
Patents
0
Programs
15
Data quality
0.89

Quick answer

guanfacine hydrochloride (INTUNIV PARTIAL CHANGE APPROVAL) is a adrenergic receptor alpha-2 agonist. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN guanfacine hydrochloride
Brand INTUNIV PARTIAL CHANGE APPROVAL
Mechanism Adrenergic receptor alpha-2 agonist
Target Adrenergic receptor alpha-2
Route ORAL
Formulation TABLET

Mechanism of action

Adrenergic receptor alpha-2 agonist

Primary target: Adrenergic receptor alpha-2

Approval history

Authority Status Date
FDA approved
PMDA approved

Pipeline programs

  1. Extended-release Guanfacine Hydrochloride Phase 3 · Takeda · Attention-deficit/Hyperactivity Disorder
  2. SPD503 (Guanfacine hydrochloride) Phase 3 · Takeda · ADHD
  3. SPD503 (Guanfacine hydrochloride) (2 mg) Phase 3 · Takeda · Attention Deficit Disorder With Hyperactivity
  4. SPD503-318 Phase 3 · Takeda · Attention Deficit Hyperactivity Disorder (ADHD)
  5. extended-release guanfacine hydrochloride (SPD503) Phase 3 · Takeda · Attention-Deficit/Hyperactivity Disorder
  6. guanfacine Phase 3 · Ultragenyx UK · Tourette Syndrome
  7. Guanfacine Phase 2 · BRIGHT MINDS BIOSCIENCES · Cocaine Related Disorders
  8. Guanfacine Phase 2 · BRIGHT MINDS BIOSCIENCES · Substance Use Disorders

Related & competitor drugs

  1. brimonidine tartrate Adrenergic receptor alpha-2 agonist
  2. clonidine hydrochloride Adrenergic receptor alpha-2 agonist
  3. dexmedetomidine hydrochloride Adrenergic receptor alpha-2 agonist
  4. methyldopa Adrenergic receptor alpha-2 agonist
  5. methyldopate hydrochloride Adrenergic receptor alpha-2 agonist
  6. mirtazapine Serotonin 2a (5-HT2a) receptor antagonist

Frequently asked questions

What is guanfacine hydrochloride?

guanfacine hydrochloride (INTUNIV PARTIAL CHANGE APPROVAL) is a adrenergic receptor alpha-2 agonist. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for guanfacine hydrochloride?

INTUNIV PARTIAL CHANGE APPROVAL is a marketed brand name for guanfacine hydrochloride. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of guanfacine hydrochloride?

guanfacine hydrochloride has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.