Phuturdex › Drugs › Tersolisib
Drugs in development · updated 13 November 2026
Tersolisib: clinical trials and development status
Other names and codes: STX-478, LY4064809
As of 13 November 2026 Tersolisib is in 3 active clinical trials (recruiting or ongoing, phases I–III) for 11 diseases. The most advanced phase is III.
Authorisation
- EU no (EMA)
- Italy not in the AIFA register
- Germany not available
- US no (FDA)
Sources: EMA, AIFA register (open data), FDA. For Germany only the EU centralised authorisation is shown: the national BfArM register is not one of our sources.
US-listed companies sponsoring active trials: Eli Lilly and Company (NYSE: LLY, 2 trials). Data from official sources, not financial advice.
Map of sites in Europe with recruitment status, every trial and an email when something changes. Full access free until 31 March 2027, no card needed.
What it is
An orally bioavailable, brain penetrative, selective inhibitor of the class I phosphatidylinositol-4,5-bisphosphate 3-kinase (PI3K) catalytic subunit alpha (phosphoinositide 3-kinase alpha; PIK3CA; PI3K p110alpha) mutant H1047X, with potential antineoplastic activity. Upon oral administration, tersolisib selectively targets and allosterically binds to the PIK3CA mutated form PIK3CA H1047X, thereby preventing the activity of the H1047X mutant. This prevents PIK3CA H1047X-mediated activation of the PI3K/Akt (protein kinase B)/mammalian target of rapamycin (mTOR) pathway. This results in both apoptosis and growth inhibition in PIK3CA H1047X mutant-expressing tumor cells. By specifically targeting the PIK3CA H1047X mutation, tersolisib may be more efficacious and less toxic than other PI3K-alpha inhibitors that are not mutant specific. Dysregulation of the PI3K/Akt/mTOR pathway is often found in solid tumors and results in the promotion of tumor cell growth, survival, and resistance to chemo- and radio-therapy.
Diseases studied
For each disease: the drug’s most advanced phase and active trials, with the reference trial on ClinicalTrials.gov.
| Disease | Most advanced phase | Active trials | Reference trial |
|---|---|---|---|
| Breast neoplasm | III | 2 | NCT07174336 |
| Metastasis | III | 1 | NCT07174336 |
| Breast disease | I–II | 1 | NCT05768139 |
| Endometrial neoplasm | I–II | 1 | NCT05768139 |
| Head and neck neoplasms | I–II | 1 | NCT05768139 |
| Head and neck squamous cell carcinoma | I–II | 1 | NCT05768139 |
| Neoplasm | I–II | 1 | NCT05768139 |
| Ovarian neoplasm | I–II | 1 | NCT05768139 |
| Uterine cervix neoplasm | I–II | 1 | NCT05768139 |
| Chronic renal insufficiency | I | 1 | NCT07924930 |
| Renal Insufficiency | I | 1 | NCT07924930 |
Sites in Europe
136 sites of the active trials in 9 European countries, 47 recruiting.
- Spain36
- Germany24
- France21
- Italy19
- Greece12
- United Kingdom8
- Belgium7
- Ireland7
- and 1 more
Sites declared by the sponsors on ClinicalTrials.gov; region worked out by Phuturdex from the geographic point. The list of sites with city and recruitment status is in the app. See the sites →
Everything on Tersolisib
In Phuturdex you get every trial with sponsors, countries and dates, development events, FDA and EMA approvals, patents and exclusivities, orphan designations and safety alerts, with PDF and Excel export. Free until 31 March 2027.
Open in Phuturdex →Source: Phuturdex analysis of ClinicalTrials.gov (U.S. National Library of Medicine), FDA and EMA data, updated 13 November 2026. Active trials = recruiting or ongoing, phases I–III. Diseases are those named by each trial (NLM MeSH terms). The estimated launch, when shown, refers to the United States and is a Phuturdex calculation described on the Method page, not official data: the drug may already be marketed in other countries.