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CTAP101 Injection
CTAP101 is a recombinant human C1-esterase inhibitor (C1-INH) that regulates complement and contact system activation to prevent hereditary angioedema attacks.
CTAP101 is a recombinant human C1-esterase inhibitor (C1-INH) that regulates complement and contact system activation to prevent hereditary angioedema attacks. Used for Hereditary angioedema (HAE) Types I and II — prophylaxis and acute attack treatment.
At a glance
| Generic name | CTAP101 Injection |
|---|---|
| Sponsor | OPKO IP Holdings II, Inc. |
| Drug class | C1-esterase inhibitor (C1-INH) replacement therapy |
| Target | C1-esterase inhibitor (C1-INH); complement and contact system regulation |
| Modality | Small molecule |
| Therapeutic area | Immunology / Rare Genetic Disorders |
| Phase | Phase 3 |
Mechanism of action
CTAP101 replaces deficient or dysfunctional C1-esterase inhibitor protein, which normally suppresses excessive activation of the complement cascade and bradykinin-generating contact system. By restoring C1-INH levels and activity, the drug prevents the uncontrolled release of vasoactive mediators that cause the characteristic swelling episodes in hereditary angioedema (HAE).
Approved indications
- Hereditary angioedema (HAE) Types I and II — prophylaxis and acute attack treatment
Common side effects
- Injection site reactions
- Headache
- Infusion-related reactions
Key clinical trials
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:
- CTAP101 Injection CI brief — competitive landscape report
- CTAP101 Injection updates RSS · CI watch RSS
- OPKO IP Holdings II, Inc. portfolio CI