Investigational Drug Information for Cediranib

What is the development status for investigational drug Cediranib?

Cediranib is an investigational drug.

There have been 102 clinical trials for Cediranib. The most recent clinical trial was a Phase 3 trial, which was initiated on November 6^th 2008.

The most common disease conditions in clinical trials are Carcinoma, Ovarian Neoplasms, and Lung Neoplasms. The leading clinical trial sponsors are National Cancer Institute (NCI), AstraZeneca, and NRG Oncology.

Summary for Cediranib

US Patents	0
International Patents	0
US Patent Applications	6,059
WIPO Patent Applications	0
Japanese Patent Applications	591
Clinical Trial Progress	Phase 3 (2008-11-06)
Vendors	70

Recent Clinical Trials for Cediranib

Title	Sponsor	Phase
Comparison of Standard of Care Treatment With a Triplet Combination of Targeted Immunotherapeutic Agents	NRG Oncology	Phase 2
Comparison of Standard of Care Treatment With a Triplet Combination of Targeted Immunotherapeutic Agents	National Cancer Institute (NCI)	Phase 2
Olaparib With Cediranib or AZD6738 for the Treatment of Advanced or Metastatic Germline BRCA Mutated Breast Cancer	National Cancer Institute (NCI)	Phase 2

See all Cediranib clinical trials

Clinical Trial Summary for Cediranib

Top disease conditions for Cediranib

Top clinical trial sponsors for Cediranib

See all Cediranib clinical trials

US Patents for Cediranib

Drugname	Patent Number	Patent Title	Patent Assignee	Estimated Expiration

Cediranib Development Update, Clinical Status, Patent Position, and Market Projection

Last updated: September 8, 2026

Cediranib is an investigational oral VEGF receptor 1-3 tyrosine-kinase inhibitor developed by AstraZeneca as AZD2171. It has shown activity in ovarian cancer, glioblastoma, colorectal cancer, and other solid tumors, but has not received FDA approval or established a commercial market. The strongest clinical rationale remains combination treatment with olaparib in ovarian cancer, although phase III data did not support regulatory conversion.

The base-case commercial forecast is zero approved-product revenue in the near term. Any future value depends on a new registrational strategy, most likely in a biomarker-selected ovarian-cancer population or through a regional licensing transaction.

What is the current development status of cediranib?

Cediranib remains an investigational oncology drug rather than a marketed medicine. AstraZeneca conducted the major development programs, but the asset has not progressed to FDA approval.

Category	Current assessment
Generic name	Cediranib
Development code	AZD2171
Drug class	Oral VEGFR tyrosine-kinase inhibitor
Main target	VEGFR-1, VEGFR-2, VEGFR-3
Developer	AstraZeneca
Dosage form studied	Oral tablets
FDA approval	None
FDA Orange Book listing	None
Approved indication	None
Principal development area	Ovarian cancer, particularly in combination with olaparib
Commercial status	No approved commercial product
Biosimilar exposure	Not applicable; cediranib is a small molecule
Generic exposure	Relevant only if a future approval occurs

Cediranib inhibits vascular endothelial growth factor signaling, which is central to tumor angiogenesis. Its development strategy shifted from monotherapy toward combination therapy after single-agent activity proved insufficient to support broad registration.

Which clinical indications have been studied for cediranib?

Cediranib has been evaluated across several solid tumors, but ovarian cancer produced the clearest late-stage development path.

Ovarian cancer

The ICON6 study evaluated cediranib with platinum-based chemotherapy followed by cediranib maintenance in patients with relapsed platinum-sensitive ovarian cancer. The trial reported a progression-free-survival benefit compared with chemotherapy alone. The magnitude was clinically relevant, but the development program did not produce a global regulatory approval.

A separate phase II study evaluated cediranib plus olaparib in recurrent ovarian cancer. The combination produced longer progression-free survival than olaparib alone in the reported study population, including patients without a BRCA mutation. The finding supported further development but did not establish a registrational indication by itself.

The randomized NRG-GY004 phase III study compared:

• Platinum chemotherapy
• Olaparib monotherapy
• Cediranib plus olaparib

The cediranib-plus-olaparib regimen did not meet the study’s primary progression-free-survival objective against platinum chemotherapy. The result materially reduced the probability of near-term approval in ovarian cancer. [1, 2]

Glioblastoma

Cediranib was studied in glioblastoma because VEGF signaling is important in tumor-associated vascular permeability and angiogenesis. Clinical activity was observed in some studies, including work involving recurrent glioblastoma and combinations with radiotherapy or other anticancer agents. The program did not become a late-stage registration opportunity.

Colorectal cancer

Cediranib was investigated with chemotherapy in metastatic colorectal cancer. The drug showed antiangiogenic activity, but development did not establish a differentiated benefit sufficient to compete with approved VEGF-pathway therapies such as bevacizumab and aflibercept.

Other solid tumors

Studies also included non-small-cell lung cancer, renal cancer, breast cancer, and other advanced malignancies. These programs were exploratory and did not produce an approved indication.

What did the major cediranib clinical trials show?

Trial or program	Disease setting	Regimen	Key outcome	Development implication
ICON6	Relapsed platinum-sensitive ovarian cancer	Chemotherapy with cediranib followed by cediranib maintenance	Improved progression-free survival versus chemotherapy alone	Supported ovarian-cancer activity but did not lead to approval
Cediranib plus olaparib phase II	Recurrent ovarian cancer	Cediranib plus olaparib versus olaparib	Improved progression-free survival in the study population	Created a combination-development rationale
NRG-GY004	Platinum-sensitive recurrent ovarian cancer	Platinum chemotherapy, olaparib, or cediranib plus olaparib	Combination did not demonstrate the required superiority over chemotherapy	Major setback for registration
Glioblastoma studies	Recurrent or newly diagnosed glioblastoma	Cediranib alone or in combinations	Signals of activity in selected studies	No approved development path
Colorectal-cancer studies	Advanced colorectal cancer	Cediranib with chemotherapy	Limited differentiation against established antiangiogenic agents	Program did not progress to approval

The central commercial problem is that cediranib’s efficacy signal has been strongest in combination settings, while combination development increases toxicity, trial complexity, pricing pressure, and dependence on a partner drug.

Is cediranib approved by the FDA?

No. The FDA has not approved cediranib for ovarian cancer, glioblastoma, colorectal cancer, or any other disease.

Cediranib therefore has:

• No FDA-approved label
• No U.S. prescribing information
• No FDA-recognized indication
• No Orange Book-listed drug product
• No approved generic-equivalence pathway
• No U.S. approved-product revenue base

The absence of approval also means that cediranib has not generated the conventional Hatch-Waxman exclusivity profile associated with an approved new drug.

What is the Orange Book status of cediranib?

Cediranib has no meaningful Orange Book status because no cediranib product has been approved and listed by the FDA.

That distinction is important for competitive analysis. A future sponsor could face patent challenges if it obtained approval, but current generic entry cannot occur through an ANDA against an Orange Book-listed reference product because no such reference product exists.

The relevant future pathways would be:

1. A new drug application for cediranib monotherapy or combination use.
2. Patent listing for approved formulation, composition, or method-of-use claims.
3. Paragraph IV challenges by generic manufacturers after any future Orange Book listing.
4. Potential 505(b)(2) development if the sponsor relied on existing safety or pharmacology information while pursuing a differentiated formulation or indication.

When does cediranib lose exclusivity?

Cediranib has no active U.S. regulatory exclusivity period because it has no FDA approval.

The drug’s original composition and formulation patent protection is likely to have expired or to be close to expiration, depending on the specific jurisdiction, patent family, patent-term adjustment, and claim scope. The original discovery and development work dates to the late 1990s and early 2000s. A standard U.S. patent term measured from the earliest effective nonprovisional filing would therefore generally place basic composition protection in the late 2010s or 2020s.

The commercial significance is limited because expired or expiring patent rights do not create a generic market without an approved reference product. If cediranib is revived, value would likely depend on:

• New use patents
• Combination patents
• Patient-selection claims
• Sustained-release or modified-release formulations
• Manufacturing and solid-state claims
• Regulatory exclusivity attached to a new approval

What patents protect cediranib?

The original intellectual-property estate centered on AstraZeneca’s quinazoline-based VEGF receptor inhibitor chemistry, including cediranib composition claims and related pharmaceutical compositions.

The relevant patent categories are:

Patent category	Commercial relevance
Composition-of-matter patents	Core protection for cediranib and related quinazoline compounds
Pharmaceutical-composition patents	Protection for tablet formulations, excipients, salts, and dosage forms
Method-of-treatment patents	Potential protection for ovarian cancer, glioblastoma, colorectal cancer, and other indications
Combination patents	Potential protection for cediranib with olaparib or cytotoxic chemotherapy
Patient-selection patents	Potential protection for biomarker-defined or BRCA-independent populations
Manufacturing patents	Potential barriers involving intermediates, crystallization, purification, and scale-up

No Orange Book-listed U.S. patents currently protect an approved cediranib product. Patent strength is therefore prospective rather than an active barrier to generic competition.

How strong is the cediranib patent estate?

The original composition estate is weaker as a commercial asset because of age and the absence of an approved product. Later method-of-use and combination claims could have greater remaining term if properly prosecuted, but these claims would face several challenges:

• Dependence on clinical efficacy in a defined population
• Obviousness arguments based on prior VEGF inhibitors and PARP inhibitors
• Written-description and enablement scrutiny for broad combination claims
• Difficulty obtaining broad claims after negative or inconclusive phase III data
• Limited commercial value without a registrational development plan

Manufacturing and formulation claims could provide incremental protection, but they would not compensate for an absence of clinical differentiation.

Are there paragraph IV challenges to cediranib?

No material U.S. Paragraph IV dispute has emerged because cediranib has no approved reference product listed in the Orange Book.

If cediranib were approved in the future, generic challengers could target any listed patents covering:

• The active ingredient
• A specific tablet strength
• Combination use
• A treatment method
• A formulation or dosing schedule

A generic launch before patent expiry would depend on the scope of those claims, the absence of a valid listed patent, or a successful Paragraph IV litigation strategy. The current probability of a conventional ANDA-driven launch is low because there is no approved reference product.

What is the litigation and settlement status for cediranib?

There is no major active U.S. patent litigation or widely reported Paragraph IV settlement involving an approved cediranib product.

The principal legal risk is not current generic litigation. It is whether any future sponsor could assemble sufficient patent and regulatory protection to justify renewed development. A new sponsor would also need to evaluate prior clinical data, patent-family status, ownership, prosecution history, and any continuing obligations under AstraZeneca’s development agreements.

No major publicly established licensing transaction has converted cediranib into a separately commercialized product. AstraZeneca retained the central development role in the principal ovarian-cancer programs.

What is the competitive position of cediranib?

Cediranib competes in two crowded categories: antiangiogenic agents and combination regimens for ovarian cancer.

Drug or class	Competitive advantage over cediranib
Bevacizumab	Established ovarian-cancer approvals, clinical familiarity, and commercial infrastructure
Pazopanib	Approved oral antiangiogenic product in selected cancers
Sorafenib	Broad oncology development history and established generic availability
Axitinib	Approved VEGFR-directed therapy with a defined renal-cell-cancer market
Olaparib	Approved PARP inhibitor with established biomarker-driven use
Niraparib	Approved PARP inhibitor and ovarian-cancer commercial presence
Rucaparib	Approved PARP inhibitor with ovarian-cancer history
Mirvetuximab soravtansine	Targeted ovarian-cancer option for folate-receptor-alpha-positive disease
Other VEGF inhibitors	Established clinical evidence, supply chains, and payer familiarity

Cediranib’s principal differentiation would be oral administration and potential synergy with PARP inhibition. That advantage is insufficient by itself. A commercial product would need a clear efficacy or biomarker benefit over established PARP and antiangiogenic combinations.

What is the market projection for cediranib?

The base-case forecast is no commercial sales because cediranib has no approved indication and no active late-stage program with a clear regulatory path.

Scenario-based market outlook

Scenario	Probability assessment	Commercial outcome
Base case: development remains inactive	Highest	No commercial revenue
Re-entry through academic or investigator-led trials	Moderate	Limited trial supply or licensing value; no near-term product sales
New registration trial in ovarian cancer	Low	Potential niche product if efficacy is reproduced
Approval of cediranib plus olaparib in a biomarker-selected population	Low	Possible specialty-oncology market, but dependent on renewed evidence
Regional approval or licensing	Low	Localized revenue opportunity with limited global value
Broad monotherapy approval	Very low	Unlikely because historical development did not establish sufficient differentiation

A realistic approved-product market, if redevelopment succeeded, would probably be narrower than the market for established VEGF inhibitors. Cediranib would likely be positioned in recurrent ovarian cancer, a combination regimen, or a biomarker-selected population rather than as a broad oncology drug.

Revenue exposure

There is no current branded-product revenue exposure attributable to cediranib. AstraZeneca’s historical financial performance was not dependent on cediranib, and the drug does not represent a current material revenue contributor.

Potential value would arise through:

• Sale or licensing of rights
• Combination-development milestones
• Royalty income
• Reuse of clinical and manufacturing data
• A new patent estate around a differentiated regimen

Without a positive registrational trial, these values remain limited.

What generic launch risks exist for cediranib?

Generic launch risk is currently theoretical because cediranib is not approved.

If a sponsor obtained approval, the principal risks would be:

1. Early generic interest in an orally administered small molecule.
2. Limited ability to rely on long-lived composition patents.
3. Potential challenges to method-of-use claims.
4. Weak protection if the label contains broad or easily designed-around indications.
5. Price erosion from multiple generic manufacturers after approval.
6. Competition from existing VEGF inhibitors and low-cost off-patent therapies.

A future sponsor would need to protect the product through a differentiated formulation, a narrow but clinically meaningful use, combination claims, or regulatory exclusivity. Conventional composition protection alone would likely be insufficient.

How does cediranib compare with olaparib?

Cediranib and olaparib have different commercial profiles.

Factor	Cediranib	Olaparib
Mechanism	VEGFR inhibitor	PARP inhibitor
Regulatory status	Investigational	FDA-approved
Main commercial use	None	Multiple oncology indications
Biomarker strategy	Angiogenesis and combination biology	BRCA and homologous-recombination deficiency
Development maturity	Late-stage historical studies, no approval	Established global product
Patent and exclusivity position	No current Orange Book product	Active and historical approved-product protections
Commercial risk	Clinical redevelopment risk	Lifecycle management and generic-entry risk
Combination rationale	May enhance PARP-inhibitor activity	Partner drug in cediranib combination studies

The cediranib-plus-olaparib concept remains scientifically relevant, but olaparib’s established label and commercial position would give the combination a partner-driven rather than cediranib-driven value proposition.

What is the outlook for cediranib through 2026?

Cediranib’s outlook is low probability and option-like. The drug has a credible mechanism and historical clinical activity, but its development record does not support a near-term launch forecast.

The most plausible catalysts would be:

• A new sponsor acquiring rights
• A biomarker-defined ovarian-cancer study
• Positive prospective data in a PARP-inhibitor combination
• A regional development decision
• New formulation or dosing technology
• A clinical finding that identifies a population with substantially greater benefit

Absent one of these events, cediranib should be valued as an inactive or dormant oncology asset rather than as a near-commercial product.

Key Takeaways

• Cediranib is an investigational oral VEGFR inhibitor developed by AstraZeneca.
• It has no FDA approval, Orange Book listing, approved indication, or current branded revenue.
• Ovarian cancer is the most advanced development area.
• ICON6 and earlier cediranib-plus-olaparib studies showed activity, but NRG-GY004 did not support a clear registration path.
• There is no material current Paragraph IV litigation or generic challenge.
• The original composition patent estate is aged; future value would depend on new combination, formulation, method-of-use, or patient-selection protection.
• Cediranib is a small molecule, so biosimilar risk does not apply.
• The base-case market projection is zero near-term commercial revenue.
• A future market would likely be limited to a specialized ovarian-cancer combination or biomarker-defined population.

FAQs About Cediranib Development and Commercial Potential

Is cediranib the same as AZD2171?

Yes. AZD2171 is AstraZeneca’s development code for cediranib.

Does cediranib have an FDA-approved generic?

No. Cediranib has no FDA-approved reference product and no approved generic version.

Could cediranib still be approved for ovarian cancer?

Approval is possible only through renewed clinical development. Historical activity alone is insufficient, and the negative or non-supportive phase III outcome substantially lowers the probability of near-term approval.

Is cediranib a biosimilar risk to bevacizumab?

No. Cediranib is an oral small-molecule VEGFR inhibitor. Bevacizumab is a biologic monoclonal antibody. Cediranib would compete clinically with bevacizumab but would not be a biosimilar.

What would most increase cediranib’s valuation?

The strongest value catalyst would be prospective evidence showing that cediranib produces a durable benefit in a clearly defined ovarian-cancer population, particularly when combined with a PARP inhibitor and supported by a defensible patent or regulatory-exclusivity strategy.

References

1. AstraZeneca. (2023). Annual report and Form 20-F 2022. AstraZeneca PLC.

2. National Cancer Institute. (n.d.). NRG-GY004: A randomized phase II/III study of cediranib and olaparib versus platinum-based chemotherapy in recurrent platinum-sensitive ovarian cancer. ClinicalTrials.gov.

3. Liu, J. F., Barry, W. T., Birrer, M., Lee, J. M., Buckanovich, R. J., Fleming, G. F., Rimel, B. J., Buss, M. K., Chon, H. S., O'Malley, D. M., Hensley, M. L., Armstrong, D. K., & Matulonis, U. A. (2014). Combination cediranib and olaparib versus olaparib alone for women with recurrent platinum-sensitive ovarian cancer: A randomised phase 2 study. The Lancet Oncology, 15(11), 1207-1214.

4. Ledermann, J. A., Embleton, A. C., Verschraegen, C., Tomei, D., Mackay, H., Aghajanian, C., Bookman, M. A., Burger, R. A., Mantia-Smaldone, G., Hall, M., & others. (2016). Cediranib in patients with relapsed platinum-sensitive ovarian cancer: The ICON6 randomized clinical trial. The Lancet, 387(10023), 1066-1074.

5. U.S. Food and Drug Administration. (n.d.). Orange Book: Approved drug products with therapeutic equivalence evaluations. FDA.

6. AstraZeneca. (n.d.). Cediranib clinical development information. AstraZeneca PLC.