Drugs / PEP07
last change Apr 2024 re-read 3 minutes ago

PEP07

Small molecule

Developed for
acute myeloid leukemia · mantle cell lymphoma · metastatic neoplasm · neoplasm
Investigated by
PharmaEngine

Trials 2

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1 NCT05983523 Mar 2024 → Feb 2027 expected metastatic neoplasm, neoplasm PharmaEngine Recruiting No outcome recorded
Phase 1 NCT05659732 Jul 2023 → Dec 2026 expected acute myeloid leukemia, mantle cell lymphoma PharmaEngine Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 3

DateIssuerRelease
2023-09-22 PharmaEngine Regulatory PharmaEngine announces TFDA approval of PEP07 Phase I clinical trial for solid tumor cancers pharmaengine.com ↗
PharmaEngine, Inc. (TWO:4162) announces TFDA has approved PEP07 Phase 1 clinical trial for solid tumor cancers.
2023-06-14 PharmaEngine Regulatory PharmaEngine announces Phase I clinical study of PEP07 has been approved by Taiwan Food and Drug Administration (TFDA) pharmaengine.com ↗
PharmaEngine Inc. (4162.TWO) announces Phase 1 clinical study in hematological cancer (e.g., AML or MCL) of PEP07, our product under development, has been approved by Taiwan Food and Drug Administration (TFDA).
2023-03-03 PharmaEngine Regulatory PharmaEngine announces Phase I clinical study of PEP07 has been approved by Australia HREC and acknowledged by Australia TGA pharmaengine.com ↗
PharmaEngine, Inc. (TWO:4162) announces PEP07 Phase I clinical trial in hematological cancers (e.g., AML or MCL) has been approved by Australia HREC (Human Research Ethics Committee, HREC) and acknowledged by Australia TGA (Therapeutic Goods Administration, TGA).

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as PEP07 ClinicalTrials.gov intervention name — accepted as the source's own label NCT05659732 ↗
1

NCT05983523 ↗

Action Inhibit “PEP07 is a selective Chk1 inhibitor maleate drug” NCT05659732 ↗
Modality Small molecule “small molecule inhibitor” NCT05983523 ↗
Route Oral “PEP07 will be provided as 20 mg and 150 mg strength capsules to be administrated orally.” NCT05659732 ↗