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Octanorm
Octanorm is a Biologic drug developed by Octapharma. It is currently in discontinued development.
Octanorm (human immunoglobulin 16.5% subcutaneous) is a subcutaneous immunoglobulin replacement therapy developed by Octapharma for primary immunodeficiency disorders. The drug delivers polyclonal human immunoglobulin G (IgG) via subcutaneous infusion, bypassing the intravenous route to enable home-based therapy with improved convenience and tolerability. Octanorm completed Phase 3 trials in primary immunodeficiency (PID) with 127 total enrolled patients across four studies, demonstrating efficacy and safety in both adult and pediatric populations; the product achieved EMA authorization and MHRA licensing but has since been discontinued from active development. The drug was marketed under the brand name Cutaquig in certain European markets, positioning it as a subcutaneous alternative to IV immunoglobulin therapies. Clinical differentiation centered on reduced infusion burden, improved quality of life, and lower infection rates compared to historical IV controls. The product's discontinuation reflects competitive pressures from established subcutaneous IG therapies and market consolidation within the rare disease immunology space.
At a glance
| Generic name | Octanorm |
|---|---|
| Sponsor | Octapharma |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | discontinued |
Approved indications
Common side effects
Key clinical trials
- Clinical Phase 3 Study to Evaluate the Efficacy, Tolerability and Safety of Subcutaneous Human Immunoglobulin (Octanorm) in Patients With Primary Immunodeficiency Diseases. (Phase 3)
- Clinical Phase III Study to Evaluate the Pharmacokinetics, Efficacy, Tolerability and Safety of Subcutaneous Human Immunoglobulin (Octanorm 16.5%) In Patients With Primary Immunodeficiency Diseases (Phase 3)
- Title for SCGAM-03: CLINICAL PHASE III STUDY TO MONITOR THE SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES WHO HAV (Phase 3)
- Double-blind, Randomized, Placebo-Controlled Phase III Study Evaluating Efficacy and Safety of Subcutaneous Human Immunoglobulin (Octanorm) in Patients With Dermatomyositis (SCGAM-02) (Phase 3)
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:
- Octanorm CI brief — competitive landscape report
- Octanorm updates RSS · CI watch RSS
- Octapharma portfolio CI
Frequently asked questions about Octanorm
What is Octanorm?
Who makes Octanorm?
What development phase is Octanorm in?
Related
- Manufacturer: Octapharma — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing