Asset profile
Gedatolisib
Small molecule
Evidence outlook
Approved: HR+/HER2- Metastatic Breast Cancer
Regulatory approval supersedes design-level evidence grading; the trials behind approval are preserved below as the drug's evidence history.
Also in development:Breast Cancer · Phase 3
How the evidence outlook works ↗
Featured trials
The studies most instrumental to this drug's clinical progression, individually graded on design and result. Pick an indication; Research unlocks the trials, endpoints, key results and grades.
Competitive landscape
61 competitors in this universe: 0 direct rivals (same mechanism and indication), 0 same-class, 61 same-indication.
| Drug | Stage | Modality | Mechanism | Evidence signal | Reported efficacygraded featured trials |
|---|---|---|---|---|---|
| Gedatolisib: this drug | Approved | Small molecule | PI3K (class I isoforms) and mTORC1/mTORC2 | ||
| Abemaciclib (Verzenio) | Approved | Small molecule | CDK4 and CDK6 | ||
| Alpelisib (BYL719) | Approved | Small molecule | PI3K-alpha | ||
| Anastrozole | Approved | Small molecule | Aromatase | ||
| Capecitabine | Approved | Small molecule | Fluoropyrimidine (antimetabolite) | ||
| Capivasertib | Approved | Small molecule | AKT (inhibitor) | ||
| Datopotamab Deruxtecan | Approved | Antibody–drug conjugate | TROP2 | ||
| Denosumab | Approved | Monoclonal antibody | RANKL | ||
| Docetaxel | Approved | Small molecule | Microtubules (tubulin) | ||
| Elacestrant | Approved | Small molecule | Estrogen receptor | ||
| Eribulin Mesylate | Approved | Small molecule | Tubulin / microtubules | ||
| Everolimus | Approved | Small molecule | mTOR kinase, mTOR (mTORC1) (inhibitor) | ||
| Exemestane | Approved | Small molecule | Aromatase | ||
| Fulvestrant (Faslodex) | Approved | Small molecule | Estrogen receptor | ||
| Gemcitabine | Approved | Small molecule | ribonucleotide reductase / DNA polymerase (dCTP competition) | ||
| Goserelin | Approved | Peptide | GnRH receptor (agonist) |
…and 46 more. Research shows the complete landscape.
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
(3 total)
Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.
2028 (2)
January 2028 (1)
What to watch
August 2028 (1)
What to watch
2029 (1)
March 2029 (1)
What to watch
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.