Quick answers
- What is Duvelisib used for?
- The FDA-approved label (Copiktra, Secura Bio, Inc, December 18, 2025) says: “COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines of systemic therapy. Limitations of Use: COPIKTRA is not indicated or recommended for the treatment of any patients with CLL or SLL as initial or second line treatment due to an increased risk of treatment-related mortality. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Duvelisib have a boxed warning?
- Yes. The FDA label for Copiktra has a boxed warning (“WARNING: TREATMENT-RELATED MORTALITY AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, AND PNEUMONITIS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Duvelisib?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Duvelisib been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Duvelisib?
- 1 company lists prescription products of Duvelisib in the FDA NDC Directory, including Secura Bio, Inc.
What Duvelisib is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines of systemic therapy. Limitations of Use: COPIKTRA is not indicated or recommended for the treatment of any patients with CLL or SLL as initial or second line treatment due to an increased risk of treatment-related mortality. …
— FDA label: Copiktra, Secura Bio, Inc, effective December 18, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: TREATMENT-RELATED MORTALITY AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, AND PNEUMONITIS
. Read it on the full label →
Forms and how it is given
| Dosage forms | Capsule |
|---|---|
| Route | Oral |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Copiktra |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Secura Bio, Inc2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA211155 COPIKTRA | Secura | September 24, 2018 | 7, latest October 24, 2025 2025: REMS · 2025: REMS · 2024: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2058514, 2058520, 2058523, 2058525 |
|---|---|
| SPL set ID of the quoted label | e3c5ac56-e1f6-473a-bc73-687836534780 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA211155 |
| Active ingredients (FDA) | DUVELISIB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Copiktra, Secura Bio, Inc, effective December 18, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →