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Pegylated Liposomal Doxorubicin · ATI-0918, PLD

Small molecule · Inhibitor of DNA topoisomerase II (TOP2A) · developed by Merck Sharp & Dohme LLC

Phase 3 Most advanced trial

MRK Developer

8 Registered trials

What is Pegylated Liposomal Doxorubicin?

Pegylated liposomal doxorubicin is a liposome-encapsulated form of the anthracycline doxorubicin hydrochloride. Doxorubicin intercalates between DNA base pairs and blocks topoisomerase II during replication, causing DNA breaks and apoptosis, and the liposomal delivery is intended to improve tumor penetration and reduce cardiac toxicity. It is being studied in ovarian, fallopian tube, peritoneal and breast cancers.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as: ATI-0918, PLD, Caelyx, Dox-SL, Doxil, Doxilen
Drug type: Small molecule
Targets: DNA topoisomerase II (TOP2A)
Mechanism: Inhibitor of DNA topoisomerase II (TOP2A)
Pathways: DNA repair, apoptosis, reactive oxygen species generation and lipid peroxidation
Therapy area: Oncology
Developer: Merck Sharp & Dohme LLC (MRK)
Also in trials of: AAPG, APRE, AZN, CLDX, IMNN, LLY
FDA status: Investigational, not approved in the US. Most advanced trial: Phase 3

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT07213804	Phase 3	Ovarian Neoplasms	Recruiting	LLY
NCT07060807	Phase 3	Breast Neoplasms	Recruiting	MRK
NCT02446600	Phase 3	Fallopian Tube Clear Cell Adenocarcinoma	Active not recruiting	AZN
NCT03268382	Phase 2	High-grade Serous Ovarian Cancer	Completed	APRE
NCT02098343	Phase 1/2	Platinum Sensitive Recurrent High-grade Serous Ovarian Cancer With Mutated p53	Completed	APRE
NCT06687070	Phase 1	Platinum-resistant Recurrent Ovarian Cancer	Recruiting	AAPG
NCT05029999	Phase 1	HER2-negative Breast Cancer	Recruiting	CLDX
NCT00061867	Phase 1	Prostate Cancer	Completed	IMNN

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Fallopian Tube Clear Cell AdenocarcinomaFallopian Tube Transitional Cell CarcinomaFallopian Tube Undifferentiated CarcinomaHER2-negative Breast CancerMetastatic Breast CancerOvarian Clear Cell AdenocarcinomaOvarian Endometrioid TumorOvarian Seromucinous CarcinomaOvarian Serous TumorOvarian Transitional Cell CarcinomaOvarian Undifferentiated CarcinomaRecurrent Fallopian Tube CarcinomaRecurrent Ovarian CarcinomaRecurrent Ovarian Endometrioid Adenocarcinoma

Other drugs acting on TOP2A

Doxorubicin FDA approved Amrubicin Phase 3 Berubicin Phase 2 Camsirubicin Phase 1 IMX-110 Phase 1/2

More from Merck Sharp & Dohme LLC

BCG Live FDA approved Belzutifan FDA approved Berahyaluronidase Alfa FDA approved Berahyaluronidase Alfa and Pembrolizumab FDA approved Enlicitide FDA approved Ensifentrine FDA approved Letermovir FDA approved Pembrolizumab FDA approved Probenecid FDA approved Alimatravir Phase 2 Bomedemstat Phase 2/3 Calderasib Phase 3

Sources

Updated Oct 11, 2026. Something wrong or missing? Report it on the MRK page.

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z