Last reviewed 2026-05-28 · How we verify

ddAC-CP-Olaparib

The Netherlands Cancer Institute · Phase 3 active Small molecule ✓ Verified May 2026

ddAC-CP-Olaparib is a PARP inhibitor Small molecule drug developed by The Netherlands Cancer Institute. It is currently in Phase 3 development for Advanced ovarian cancer with BRCA1 or BRCA2 mutations, Advanced breast cancer with BRCA1 or BRCA2 mutations.

ddAC-CP-Olaparib is a PARP inhibitor that works by blocking the enzyme PARP, which is involved in DNA repair.

ddAC-CP-Olaparib is a small molecule inhibitor of PARP 1, 2, and 3, used in the treatment of breast cancer. It is part of a clinical trial (NCT02810743) aimed at improving the cure rate of high-risk BRCA1-like breast cancer patients.

Likelihood of approval

61.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Oncology Phase 3 boost +3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	ddAC-CP-Olaparib
Sponsor	The Netherlands Cancer Institute
Drug class	PARP inhibitor
Target	PARP
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

By inhibiting PARP, ddAC-CP-Olaparib prevents cancer cells from repairing their DNA, leading to cell death. This mechanism is particularly effective in cancers with BRCA1 or BRCA2 mutations, which are already defective in DNA repair. As a result, ddAC-CP-Olaparib is often used in combination with other therapies to enhance its effectiveness.

Approved indications

Advanced ovarian cancer with BRCA1 or BRCA2 mutations
Advanced breast cancer with BRCA1 or BRCA2 mutations

Common side effects

Nausea
Vomiting
Fatigue
Diarrhea

Key clinical trials

Substantially Improving the Cure Rate of High-risk BRCA1-like Breast Cancer (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

ddAC-CP-Olaparib CI brief — competitive landscape report
ddAC-CP-Olaparib updates RSS · CI watch RSS
The Netherlands Cancer Institute portfolio CI

Frequently asked questions about ddAC-CP-Olaparib

What is ddAC-CP-Olaparib?

ddAC-CP-Olaparib is a PARP inhibitor drug developed by The Netherlands Cancer Institute, indicated for Advanced ovarian cancer with BRCA1 or BRCA2 mutations, Advanced breast cancer with BRCA1 or BRCA2 mutations.

How does ddAC-CP-Olaparib work?

ddAC-CP-Olaparib is a PARP inhibitor that works by blocking the enzyme PARP, which is involved in DNA repair.

What is ddAC-CP-Olaparib used for?

ddAC-CP-Olaparib is indicated for Advanced ovarian cancer with BRCA1 or BRCA2 mutations, Advanced breast cancer with BRCA1 or BRCA2 mutations.

Who makes ddAC-CP-Olaparib?

ddAC-CP-Olaparib is developed by The Netherlands Cancer Institute (see full The Netherlands Cancer Institute pipeline at /company/the-netherlands-cancer-institute).

What drug class is ddAC-CP-Olaparib in?

ddAC-CP-Olaparib belongs to the PARP inhibitor class. See all PARP inhibitor drugs at /class/parp-inhibitor.

What development phase is ddAC-CP-Olaparib in?

ddAC-CP-Olaparib is in Phase 3.

What are the side effects of ddAC-CP-Olaparib?

Common side effects of ddAC-CP-Olaparib include Nausea, Vomiting, Fatigue, Diarrhea.

What does ddAC-CP-Olaparib target?

ddAC-CP-Olaparib targets PARP and is a PARP inhibitor.

Drug class: All PARP inhibitor drugs
Target: All drugs targeting PARP
Manufacturer: The Netherlands Cancer Institute — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Advanced ovarian cancer with BRCA1 or BRCA2 mutations
Indication: Drugs for Advanced breast cancer with BRCA1 or BRCA2 mutations

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing