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Diphtheria Antitoxin
Diphtheria Antitoxin is a Antitoxin (passive immunotherapy) Biologic drug developed by PT Bio Farma. It is currently FDA-approved for Diphtheria (treatment and prevention of complications from diphtheria toxin).
Diphtheria antitoxin is a passive immunotherapy that provides immediate neutralization of diphtheria toxin by binding and inactivating the exotoxin produced by Corynebacterium diphtheriae.
Diphtheria Antitoxin is a protein-based treatment used to counteract diphtheria, a bacterial infection. It is studied in clinical trials for various conditions, including diphtheria, pertussis, tetanus, hepatitis B, and Haemophilus infections, often in combination with other vaccines.
At a glance
| Generic name | Diphtheria Antitoxin |
|---|---|
| Sponsor | PT Bio Farma |
| Drug class | Antitoxin (passive immunotherapy) |
| Target | Diphtheria toxin |
| Modality | Biologic |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
The antitoxin consists of antibodies (typically from immunized horses or humans) that directly bind to circulating diphtheria toxin, preventing it from damaging tissues. This provides rapid but temporary protection, as the antibodies are gradually cleared from the body. It is most effective when administered early in infection, before toxin has caused irreversible tissue damage.
Approved indications
- Diphtheria (treatment and prevention of complications from diphtheria toxin)
Common side effects
- Serum sickness
- Hypersensitivity reactions
- Anaphylaxis
Key clinical trials
- Post Marketing Surveillance of Diphtheria Antitoxin (DAT) (PHASE4)
- A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject (PHASE3)
- Study of Quinvaxem for Vaccination Against Diphtheria, Pertussis, Tetanus, Hepatitis B and Diseases Caused by Haemophilus Influenzae Type B (PHASE3)
- Study to Assess if Quinvaxem Can be Interchanged With Other Pentavalent Vaccines During Standard Childhood Vaccination (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Diphtheria Antitoxin CI brief — competitive landscape report
- Diphtheria Antitoxin updates RSS · CI watch RSS
- PT Bio Farma portfolio CI
Frequently asked questions about Diphtheria Antitoxin
What is Diphtheria Antitoxin?
How does Diphtheria Antitoxin work?
What is Diphtheria Antitoxin used for?
Who makes Diphtheria Antitoxin?
What drug class is Diphtheria Antitoxin in?
What development phase is Diphtheria Antitoxin in?
What are the side effects of Diphtheria Antitoxin?
What does Diphtheria Antitoxin target?
Related
- Drug class: All Antitoxin (passive immunotherapy) drugs
- Target: All drugs targeting Diphtheria toxin
- Manufacturer: PT Bio Farma — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Diphtheria (treatment and prevention of complications from diphtheria toxin)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing