Wednesday, July 8, 2026

Drug profile · INN

clonidine

clonidine (APO-CLONIDINE) is a adrenergic receptor alpha-2 agonist. Associated with Apotex Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved TGA: approved
US status approved
Patents linked 3
Pipeline programs 8
News articles 0
Drug details — clonidine
US status
approved
Class
Route
ORAL
Patents
3
Programs
8
Data quality
0.84

Quick answer

clonidine (APO-CLONIDINE) is a adrenergic receptor alpha-2 agonist. Associated with Apotex Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN clonidine
Brand APO-CLONIDINE
Mechanism Adrenergic receptor alpha-2 agonist
Target Adrenergic receptor alpha-2
Route ORAL
Formulation SYSTEM
Originator Apotex Pty Ltd

Mechanism of action

Adrenergic receptor alpha-2 agonist

Primary target: Adrenergic receptor alpha-2

Approval history

Authority Status Date
FDA approved
TGA approved

Pipeline programs

  1. Clonidine HCL Phase 3 · BRIGHT MINDS BIOSCIENCES · Neonatal Abstinence Syndrome
  2. Clonidine HCl Mucoadhesive Buccal Tablet Phase 3 · Monopar Therapeutics · Chemoradiotherapy-Induced Severe Oral Mucositis
  3. Clonidine Phase 2 · Grace Therapeutics · Pregnancy Related
  4. Clonidine Phase 2 · BRIGHT MINDS BIOSCIENCES · Opioid-Related Disorders
  5. S-1 Phase 2 · United Therapeutics Europe · Locally Advanced or Metastatic Pancreatic Cancer
  6. S-1 Phase 2 · United Therapeutics Europe · Advanced Non-Small Cell Lung Cancer
  7. TS-1 with cisplatin Phase 2 · Hospital Authority · Recurrent Gastric Cancer
  8. S-1 Approved · First People's Hospital · Pancreatic Cancer

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. guanfacine hydrochloride Adrenergic receptor alpha-2 agonist
  5. methyldopa Adrenergic receptor alpha-2 agonist
  6. methyldopate hydrochloride Adrenergic receptor alpha-2 agonist
  1. US 11090290

    Clonidine and/or clonidine derivatives for use in the prevention of skin injury resulting from radiotherapy

    Expires Mon Aug 12 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 10675271

    Clonidine and/or clonidine derivatives for use in the prevention and/or treatment of adverse side effects of chemotherapy

    Expires Mon Jun 04 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 10450340

    3′-deamino-3′-(2″-pyrroline-1″-yl)-5-imino-13-deoxyanthracyclines and methods of preparation

    Expires Mon Oct 17 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is clonidine?

clonidine (APO-CLONIDINE) is a adrenergic receptor alpha-2 agonist. Associated with Apotex Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for clonidine?

APO-CLONIDINE is a marketed brand name for clonidine. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of clonidine?

clonidine 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.