Asset profile

rilzabrutinib

Small molecule

Preview Research free. Sign in to unlock 3 full asset or company pages every day, no card needed.Sign in to unlock this page
Approvedregulatory verdict

Evidence outlook

Approved: persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response... (FDA)

This approval is for an indication outside this terminal's covered markets; the covered program shown here is investigational. Regulatory approval supersedes design-level evidence grading for the approved use.

The sponsor's 2024-05-22 release reports 36% and 25% relative risk reductions in loss-of-asthma-control events; the underlying odds ratios (0.584, 95% CI 0.253-1.349; 0.570, 95% CI 0.202-1.608) both include 1, so the registered primary endpoint was not statistically significant. Caveat: this result is taken from a company announcement or a news report of one, not from the trial registry or a peer-reviewed publication. Treat the figures as the sponsor's own statement, not as independently verified evidence.

track record: Partial signal

Source for the program status

How the evidence outlook works ↗

Competitive landscape

61 competitors in this universe: 0 direct rivals (same mechanism and indication), 1 same-class, 60 same-indication; 38 further along in development.

Unlock with Research ↗
DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Rilzabrutinib: this drugPhase 3Small moleculeBTK
PirtobrutinibPhase 3Small moleculeBTK
Albuterol (Armstrong Albuterol HFA)ApprovedSmall moleculeBeta-2 adrenergic receptor
Albuterol / Budesonide (Airsupra)ApprovedCombinationBeta-2 adrenergic receptor, Glucocorticoid receptor, Glucocorticoid receptor / Beta-2 adrenergic receptor
Albuterol HFA (Armstrong's)ApprovedSmall moleculeBeta-2 adrenergic receptor
Albuterol HFA (Proventil HFA)ApprovedSmall moleculeBeta-2 adrenergic receptor
Albuterol Sulfate (Armstrong)ApprovedSmall moleculeBeta-2 adrenergic receptor
Albuterol Sulfate (Provenetil-HFA)ApprovedSmall moleculeBeta-2 adrenergic receptor
AminophyllineApprovedSmall moleculePhosphodiesterase (multi-subtype)
Beclomethasone (QVAR)ApprovedSmall moleculeGlucocorticoid receptor
Beclomethasone Dipropionate / Formoterol Fumarate / GlycopyrrolateApprovedSmall moleculeGlucocorticoid receptor / Beta-2 adrenergic receptor / Muscarinic M3 receptor (ICS/LABA/LAMA triple combination)
Benralizumab (Fasenra)ApprovedMonoclonal antibodyIL-5 receptor alpha, IL-5 receptor alpha (IL-5Rα / CD125); Fc region additionally engages FcγRIIIa on NK cells (ADCC), IL-5 receptor alpha (IL5RA) on eosinophils/basophils
Budesonide (Pulmicort)ApprovedSmall moleculeGlucocorticoid receptor agonist
Budesonide / Formoterol Fumarate (SYMBICORT)ApprovedCombinationGlucocorticoid receptor; Beta-2 adrenergic receptor
Budesonide / Glycopyrrolate / Formoterol Fumarate (Breztri Aerosphere)ApprovedSmall moleculeGlucocorticoid receptor; Muscarinic M3; Beta-2 adrenergic
Ciclesonide (Alvesco)ApprovedSmall moleculeGlucocorticoid receptor

…and 46 more. Research shows the complete landscape.

Research

Unlock the full comparison

Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.

Upcoming events

(7 total)

Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.

2026 (2)
November 2026 (1)
Phase 3Immune ThrombocytopeniaActive not recruiting
Est. primary completion 2026-11-30 · NCT07216079 · CT.gov ↗
What to watch
Unlock with Research ↗
December 2026 (1)
Phase 2Focal Segmental Glomerulosclerosis, Glomerulonephritis Minimal LesionRecruiting
Est. primary completion 2026-12-23 · NCT06500702 · CT.gov ↗
What to watch
Unlock with Research ↗
2027 (3)
February 2027 (1)
Phase 2Graves' DiseaseRecruiting
Est. primary completion 2027-02-11 · NCT06984627 · CT.gov ↗
What to watch
Unlock with Research ↗
July 2027 (1)
Phase 3Sickle Cell DiseaseRecruiting
Est. primary completion 2027-07-23 · NCT06975865 · CT.gov ↗
What to watch
Unlock with Research ↗
November 2027 (1)
Phase 3Immune ThrombocytopeniaRecruiting
Est. primary completion 2027-11-05 · NCT07007962 · CT.gov ↗
What to watch
Unlock with Research ↗
2028 (2)
May 2028 (1)
Phase 3Autoimmune Haemolytic AnaemiaRecruiting
Est. primary completion 2028-05-31 · NCT07086976 · CT.gov ↗
What to watch
Unlock with Research ↗
June 2028 (1)
Phase 3Immunoglobulin G4 Related DiseaseRecruiting
Est. primary completion 2028-06-28 · NCT07190196 · CT.gov ↗
What to watch
Unlock with Research ↗

See the full readout calendar ↗

All registered studies

Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.

Phase 3 (7)
Phase 2 (9)
Phase 1 (4)