Tuberculin purified protein derivative

Overview

Tuberculin Purified Protein Derivative (PPD) is a sterile aqueous solution of a purified protein fraction for intradermal administration as an aid in the diagnosis of tuberculosis. The diagnostic test is commonly referred to as the Mantoux test which serves to minimize the risk of transmission of infection with Mycobacterium tuberculosis through early diagnosis and appropriate therapeutic intervention. The purified protein fraction is isolated from culture media filtrates of a human strain of Mycobacterium tuberculosis. It is included in the World Health Organization's List of Essential Medicines.

Indication

Indicated as a diagnostic agent in Mantoux Test used to detect infection with Mycobacterium tuberculosis.

Associated Conditions

Tuberculosis (TB)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein for 65-year-olds and Above	2023/06/12	NCT05899179	Phase 3	Recruiting	Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Phase IV Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein	2023/02/28	NCT05746611	Phase 4	Active, not recruiting	Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Characterization of Tissue-Specific Immune Responses to Bronchoscopic Instillation of Mycobacterial Antigens Into the Human Lung	2021/08/31	NCT05027958	Early Phase 1	Completed	National Heart, Lung, and Blood Institute (NHLBI)
Two-Stage Tuberculin (PPD) Skin Testing in Individuals With Human Immunodeficiency Virus (HIV) Infection	2001/08/31	NCT00000955	Not Applicable	Completed	National Institute of Allergy and Infectious Diseases (NIAID)

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Aplisol	TYA Pharmaceuticals	64725-0104	INTRADERMAL	5 [iU] in 0.1 mL	7/9/2015
TUBERSOL	A-S Medication Solutions	50090-1668	INTRADERMAL	5 [iU] in 0.1 mL	11/9/2021
TUBERSOL	Sanofi Pasteur Inc.	49281-752	INTRADERMAL	5 [iU] in 0.1 mL	1/25/2024
N12 IMMUNOSODE	Apex Energetics Inc.	63479-1412	SUBLINGUAL	30 [hp_X] in 1 mL	4/22/2025
TUBERSOL	Physicians Total Care, Inc.	54868-2972	INTRADERMAL	5 [iU] in 0.1 mL	5/22/2013
TUBERSOL	A-S Medication Solutions	50090-0261	INTRADERMAL	5 [iU] in 0.1 mL	11/9/2021
Aplisol	Par Pharmaceutical, Inc.	42023-104	INTRADERMAL	5 [iU] in 0.1 mL	11/1/2017
APLISOL	A-S Medication Solutions	50090-1336	INTRADERMAL	5 [iU] in 0.1 mL	11/1/2017
N12 IMMUNOSODE	Apex Energetics Inc.	63479-1412	SUBLINGUAL	30 [hp_X] in 1 mL	5/15/2025

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
TUBERCULIN PPD RT 23 AJV	AJ Vaccines A/S	SIN09944P	INJECTION	0.4 mcg/ml	8/19/1998
INFANRIX HEXA VACCINE	GLAXOSMITHKLINE BIOLOGICALS SA, GlaxoSmithKline Biologicals, GSK Biologicals SA	SIN12288P	INJECTION	10 mcg/0.5 ml	5/7/2003

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
TUBERSOL tuberculin purified protein derivative (mantoux) diagnostic antigen vial	28624	Sanofi-Aventis Australia Pty Ltd	Medicine	A	11/4/1991

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
TUBERCULIN PPD (MANTOUX)	aventis pasteur limited	00317233	Liquid - Intradermal	250 TUB / 0.1 ML	12/31/1975
TUBERSOL	Sanofi Pasteur Limited	00317268	Solution - Intradermal	5 TUB / 0.1 ML	12/31/1975
TUBERCULIN PPD (MANTOUX)	aventis pasteur limited	00316377	Liquid - Intradermal	1 TUB / 0.1 ML	12/31/1975

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

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7 months ago

A randomized, double-blind trial conducted at the Jiangsu Center for Disease Control and Prevention evaluated the accuracy of the ESAT6-CFP10 (EC) skin test compared to traditional tuberculin skin test (TST) for TB screening. The study, which included both initial testing and BCG vaccination impact assessment, provides important insights for improving tuberculosis diagnostic methods.

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