Drugs / Sapu003
last change Jul 2026 re-read 8 days ago

Sapu003

Developed for
breast carcinoma · hepatocellular carcinoma · neuroendocrine neoplasm · renal cell carcinoma · tuberous sclerosis
Investigated by
SAPU NANO (US) LLC

Trials 1

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1 NCT07369505 Dec 2025 → Jun 2026 overdue breast carcinoma, hepatocellular carcinoma, neuroendocrine neoplasm, renal cell carcinoma +1 SAPU NANO (US) LLC Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 4

DateIssuerRelease
2026-07-07 Mateon Therapeutics Results Oncotelic Successfully Completes Initial Safety Cohort of Phase 1b SP-03-B101 Trial; Independent Safety Review Committee Recommends Dose Escalation and European Expansion Underway oncotelic.com ↗
Following completion of the protocol-defined 28-day dose-limiting toxicity (DLT) evaluation period for the initial three-patient cohort, the SRC concluded that no dose-limiting toxicities (DLTs) were observed and recommended advancing the study to the next planned dose level in accordance with the study protocol.
2025-12-04 Mateon Therapeutics Results Oncotelic and Sapu Nano Announce DeciparticleTM Led Biomarker Framework Identifying Tumors Most Likely to Respond to IV Sapu003, an Intravenous Everolimus Nanomedicine oncotelic.com ↗
Oncotelic Therapeutics, Inc. (OTCQB: OTLC) 45% owned Joint Venture, Sapu Nano today announced new biomarker data identifying a molecular signature that predicts sensitivity to Sapu003 , the company's intravenous Deciparticle™ formulation of everolimus.
2025-12-03 Mateon Therapeutics Results Oncotelic and Sapu Nano Announces New PK Data Demonstrating IV Sapu003 Reduces GI Accumulation of Everolimus up to 67-Fold Compared With Oral Dosing oncotelic.com ↗
New tissue-distribution data show that Sapu003, delivered intravenously, eliminates the extreme gastrointestinal accumulation characteristic of oral everolimus.
2025-09-24 Mateon Therapeutics Regulatory Sapu Nano oncotelic.com ↗
Sapu Nano, developer of Deciparticle™, today announced that it has received approval from Australia's Human Research Ethics Committee (HREC) to begin enrolling patients in a Phase 1 human clinical trial of Sapu003-an injectable form of Everolimus-for the treatment of breast cancer.

All press releases naming this drug 10 releases

DateIssuerRelease

Evidence & citations 2 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as Sapu003 ClinicalTrials.gov intervention name — accepted as the source's own label NCT07369505 ↗
Route Intravenous “Sapu003 weekly IV at 5, 7.5 or 10 mg/m²” NCT07369505 ↗