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Chronic lymphocytic leukemia

Oncology 7 original drugs
7
Novel Drugs
8
Reformulations
0
Active Trials
7
Drug Targets

Oncology indication. Chronic lymphocytic leukemia has 7 FDA-approved novel treatments, led by Roche across 7 drug targets. Explore market leaders, treatments by mechanism, the clinical pipeline, and drug targets below.

Chronic lymphocytic leukemia Market Leaders

Companies with the most FDA-approved novel Chronic lymphocytic leukemia drugs.

Phase 3 Readouts Pro

12 active Phase 3 trials with confidence-graded completion dates.

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Q4 2026
Pirtobrutinib
Loxo Oncology, Inc.
Estimated · fresh NCT04965493
Q4 2026
Ibrutinib
Johnson & Johnson
Estimated · fresh NCT01804686
Q1 2027
Acalabrutinib
Acerta Pharma BV
Estimated · stale NCT03836261
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Anchored on CT.gov primary completion date. Topline announcements typically precede this by 3–9 months. Confidence labels combine date type (ACTUAL/ESTIMATED) with last-update freshness.

Chronic lymphocytic leukemia Treatments by Mechanism

Top 10 mechanisms across 77 industry trials with a known mechanism of action.

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Kinase Inhibitor
46 trials 18 active 8 sponsors
BCL-2 Inhibitor
10 trials 5 active 3 sponsors
CD20-directed Cytolytic Antibody
9 trials 1 active 7 sponsors
Thalidomide Analog
3 trials 1 sponsor
PI3K-delta/PI3K-gamma
3 trials 2 sponsors
Alkylating Drug
2 trials 2 sponsors
CD52-directed Cytolytic Antibody
1 trials 1 sponsor
Hematopoietic Stem Cell Mobilizer
1 trials 1 sponsor
CD19
1 trials 1 sponsor
ABL kinase/BCR-ABL/EPHA2/FYN/LCK/PDGFRβ/SRC/YES/c-KIT
1 trials 1 sponsor

MoA derived from FDA pharmClassEpc when intervention matches an approved drug. Codenamed clinical-stage assets without an approved counterpart show "—" and aren't grouped here — they're still in the phase tables below.

Chronic lymphocytic leukemia Clinical Pipeline by Phase

290 industry-sponsored trials across 114 sponsors

Precision Medicine Biomarkers

All biomarkers →

Biomarkers used for patient selection in Chronic lymphocytic leukemia

Reformulations (8 drugs) Click to expand

Reformulations are FDA-approved versions of existing molecules in new dosage forms (e.g., oral solution vs tablet, extended-release vs immediate-release). They require a new NDA but use an already-proven active ingredient.

Chronic lymphocytic leukemia Drug Targets

Molecular targets of approved and investigational Chronic lymphocytic leukemia drugs — 7 targets tracked.

Biosimilars (3 BLA approved) Click to expand

Biosimilars are biological products highly similar to FDA-approved reference biologics with no clinically meaningful differences in safety, purity, or potency.

Generic Drugs (1 ANDA approved) Click to expand

Generic drugs contain the same active ingredient as the brand-name drug and are approved via ANDA (Abbreviated New Drug Application).

Related Indications

Other Oncology indications

Drug Categories:

  • Novel Drugs: NDA Type 1/2 (new molecular entity) or original BLA
  • Reformulations: NDA Type 3/5 (new dosage form of existing molecule)
  • Biosimilars: BLA-approved biologics highly similar to reference products
  • Generics: ANDA-approved copies of small molecule drugs

View data sources and methodology