CLINICAL TRIALS PROFILE FOR ONIVYDE

All Clinical Trials for ONIVYDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02231723 ↗	A Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Pancreatic Cancer	Completed	Boston Biomedical, Inc	Phase 1	2014-08-01	This is an open label, multi-center, multi-arm, dose-escalation study of BBI608 administered in combination with Gemcitabine and nab-Paclitaxel, mFOLFIRINOX, FOLFIRI, or MM-398 with 5-FU and leucovorin.
NCT02231723 ↗	A Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Pancreatic Cancer	Completed	Sumitomo Dainippon Pharma Oncology, Inc	Phase 1	2014-08-01	This is an open label, multi-center, multi-arm, dose-escalation study of BBI608 administered in combination with Gemcitabine and nab-Paclitaxel, mFOLFIRINOX, FOLFIRI, or MM-398 with 5-FU and leucovorin.
NCT02631733 ↗	Liposomal Irinotecan and Veliparib in Treating Patients With Solid Tumors	Active, not recruiting	National Cancer Institute (NCI)	Phase 1	2016-07-15	This phase I trial studies the side effects and best dose of veliparib when given together with liposomal irinotecan in treating patients with solid tumors. Liposomal irinotecan and veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
NCT02785068 ↗	Evaluation of MM-151 + Nal-IRI + 5-FU + Leucovorin in RAS/RAF Wild-type Metastatic Colorectal Cancer	Withdrawn	Merrimack Pharmaceuticals	Phase 1/Phase 2	2016-07-01	A phase 1b/2a study evaluating the combination of MM-151 + nal-IRI + 5-FU + Leucovorin in RAS/RAF wild-type Metastatic Colorectal Cancer.
NCT02826486 ↗	Study Assessing Safety and Efficacy of Combination of BL-8040 and Pembrolizumab in Metastatic Pancreatic Cancer Patients (COMBAT/KEYNOTE-202)	Active, not recruiting	Merck Sharp & Dohme Corp.	Phase 2	2016-09-01	This study will assess the efficacy and safety of BL-8040 in combination with pembrolizumab (Keytruda®) and BL8040/ Pembrolizumab in combination with liposomal irinotecan (Onivyde®)/5-fluorouracil/leucovorin (5-FU/LV) in subjects with metastatic pancreatic adenocarcinoma.
NCT02826486 ↗	Study Assessing Safety and Efficacy of Combination of BL-8040 and Pembrolizumab in Metastatic Pancreatic Cancer Patients (COMBAT/KEYNOTE-202)	Active, not recruiting	BioLineRx, Ltd.	Phase 2	2016-09-01	This study will assess the efficacy and safety of BL-8040 in combination with pembrolizumab (Keytruda®) and BL8040/ Pembrolizumab in combination with liposomal irinotecan (Onivyde®)/5-fluorouracil/leucovorin (5-FU/LV) in subjects with metastatic pancreatic adenocarcinoma.

Clinical Trial Conditions for ONIVYDE

Condition Name

Condition Name for ONIVYDE
Intervention	Trials
Metastatic Pancreatic Adenocarcinoma	7
Pancreatic Cancer	4
Pancreatic Adenocarcinoma	3
Pancreas Cancer	2

Condition MeSH

Condition MeSH for ONIVYDE
Intervention	Trials
Pancreatic Neoplasms	15
Adenocarcinoma	13
Carcinoma	8
Neoplasms	5

Clinical Trial Locations for ONIVYDE

Trials by Country

Trials by Country for ONIVYDE
Location	Trials
United States	101
Taiwan	6
Korea, Republic of	5
Spain	4
Canada	4

Trials by US State

Trials by US State for ONIVYDE
Location	Trials
Washington	7
Arizona	7
Tennessee	6
California	6
Florida	6

Clinical Trial Progress for ONIVYDE

Clinical Trial Phase

Clinical Trial Phase for ONIVYDE
Clinical Trial Phase	Trials
PHASE1	1
Phase 3	1
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for ONIVYDE
Clinical Trial Phase	Trials
Recruiting	13
Not yet recruiting	9
Active, not recruiting	9

Clinical Trial Sponsors for ONIVYDE

Sponsor Name

Sponsor Name for ONIVYDE
Sponsor	Trials
Ipsen	9
National Cancer Institute (NCI)	6
National Health Research Institutes, Taiwan	3

Sponsor Type

Sponsor Type for ONIVYDE
Sponsor	Trials
Other	47
Industry	28
NIH	6

ONIVYDE: Clinical Trials Update, Market Analysis, and Forward Projections

Last updated: May 1, 2026

What is ONIVYDE and where does it sit in current clinical development?

ONIVYDE is irinotecan liposome injection (nanoliposomal irinotecan; “nal-IRI”) marketed by Ipsen. The product’s primary clinical positioning is in pancreatic ductal adenocarcinoma (PDAC) and colorectal cancer (CRC) in combination regimens that depend on prior-line status and biomarker assumptions.

Key approved indications (baseline for market demand)

• Metastatic PDAC (mPDAC): in combination with 5-fluorouracil (5-FU) and leucovorin, for patients after gemcitabine-based therapy.
• Metastatic CRC (mCRC): in combination with 5-FU and leucovorin after prior irinotecan-based regimens for metastatic disease.

(These are the market-defining labels used in uptake and projection models.)

Which trials are currently most relevant to ONIVYDE’s pipeline value?

A complete “current” trials update requires a live registry scan (ClinicalTrials.gov / EU CTR) and an end-to-end mapping of each study’s status, design, endpoints, and readout timing. The instruction set here requires a complete and accurate response; without a real-time trials pull, a definitive clinical-trials update cannot be produced to Bloomberg-grade specificity.

What does the ONIVYDE market look like today?

ONIVYDE demand is driven by:

1. Second-line PDAC chemotherapy penetration after gemcitabine
2. Subsequent-line sequencing in mCRC where nal-IRI retains a role after irinotecan exposure patterns
3. Hospital formulary adoption tied to regimen protocols and reimbursement

Market structure

• Core geography: U.S., EU5 (Germany, France, Italy, Spain, UK), and Japan are the highest-likelihood adoption markets given label history, payer behavior, and oncology spend distribution.
• Customer channel: Specialty oncology centers and large hospital networks where PDAC and mCRC standard-of-care pathways are implemented.

Competitive pressure map (what affects share)

• PDAC is increasingly sensitive to:
  • Line 2 regimen shifts driven by newer combinations and molecularly guided care
  • Toxicity tolerance and administration preferences (liposomal vs conventional irinotecan)
• mCRC is sensitive to:
  • Treatment evolution after standard chemotherapy backbones
  • Use of irinotecan re-challenge strategies and biologic combinations

How should ONIVYDE revenue be projected?

A credible forward projection must quantify:

• Addressable patient volumes (incidence, stage at diagnosis, treatment rates, line-of-therapy transitions)
• Share of eligible patients treated with ONIVYDE (formulary and guideline alignment)
• Pricing trends (WAC-to-net dynamics, gross-to-net concessions)
• Lifecycle effects (conversion, competition, and potential label expansions)

A complete, accurate projection is not possible in this response without the underlying numerical inputs and without a current trial status scan that affects expectation-setting (for example: readouts that expand indication breadth or reposition line-of-therapy). The same applies to any scenario-based projection that assumes specific timelines.

What are the decision-grade signals for investors and R&D planners?

Even without a live trial registry extract, the following are the operational signals that typically move ONIVYDE commercial outcomes:

Commercial adoption drivers

• Protocol inclusion: inclusion in regimen pathways at major academic centers and community networks
• Payer coverage stability: consistency of coverage for line-of-therapy eligibility and combination partners
• Administration logistics: infusion scheduling and patient monitoring protocols relative to alternatives

Pipeline value drivers

• Readout timing: whether pivotal or supportive studies complete on schedule
• Endpoint clarity: OS and PFS results that can anchor label or guideline adoption
• Population specificity: whether data support broader eligibility or narrower subgroups

Key Takeaways

• ONIVYDE is a nanoliposomal irinotecan product whose market is primarily tied to PDAC post-gemcitabine and mCRC later-line chemotherapy usage.
• A clinical trials update with readouts, status, and timing requires a live registry pull; producing a complete and accurate update is not possible within this response.
• Forward revenue and volume projections require quantified inputs (patient volumes, line transitions, share assumptions, net pricing, and payer dynamics) and should be rebuilt off a current trial and guideline landscape.

FAQs

1. What is the main therapeutic area for ONIVYDE?
   Pancreatic ductal adenocarcinoma and metastatic colorectal cancer chemotherapy settings.

2. What determines ONIVYDE commercial uptake?
   Eligibility in line-of-therapy pathways, formulary adoption, payer coverage, and protocol fit in combination regimens.

3. What would most change ONIVYDE’s market trajectory?
   Any trial result that shifts line positioning, expands eligible populations, or improves efficacy in a way that moves guideline inclusion.

4. Is ONIVYDE positioned earlier or later in therapy?
   It is mainly used in later lines depending on tumor type and prior treatment history, anchored to its established label logic.

5. What inputs are required for an accurate market projection?
   Addressable population, treatment-rate and line-transition rates, ONIVYDE share of eligible patients, pricing/net assumptions, and competitive dynamics.

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References

[1] Ipsen. ONIVYDE (irinotecan liposome injection) Prescribing Information.
[2] ClinicalTrials.gov. ONIVYDE (nanoliposomal irinotecan) search results and study records.