Wednesday, July 8, 2026

Drug profile · INN

nizatidine

nizatidine (NIZAC) is a histamine h2 receptor antagonist. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved TGA: approved
US status approved
Patents linked 0
Pipeline programs 3
News articles 0
Drug details — nizatidine
US status
approved
Class
Route
ORAL
Patents
0
Programs
3
Data quality
0.89

Quick answer

nizatidine (NIZAC) is a histamine h2 receptor antagonist. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN nizatidine
Brand NIZAC
Mechanism Histamine H2 receptor antagonist
Target Histamine H2 receptor
Route ORAL
Formulation CAPSULE

Mechanism of action

Histamine H2 receptor antagonist

Primary target: Histamine H2 receptor

Approval history

Authority Status Date
FDA approved
TGA approved

Pipeline programs

  1. KL264-01 Phase 2 · Anaxis Pharma · Metastatic or locally advanced unresectable solid tumors pro
  2. SKB264-II-04 Phase 2 · Anaxis Pharma · Advanced or Metastatic Non-small Cell Lung Cancer
  3. Nizatidine Phase 1 · ADIAL PHARMACEUTICALS · Gastroparesis

Related & competitor drugs

  1. cimetidine Histamine H2 receptor antagonist
  2. cimetidine hydrochloride Histamine H2 receptor antagonist
  3. famotidine Histamine H2 receptor antagonist
  4. ranitidine hydrochloride Histamine H2 receptor antagonist
  5. betazole hydrochloride Histamine H2 receptor agonist
  6. methantheline bromide Histamine H2 receptor antagonist

Frequently asked questions

What is nizatidine?

nizatidine (NIZAC) is a histamine h2 receptor antagonist. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for nizatidine?

NIZAC is a marketed brand name for nizatidine. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of nizatidine?

nizatidine 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.