Last updated: September 25, 2026
CC-99677 is an investigational oral cereblon E3 ligase modulator developed by Celgene, now part of Bristol Myers Squibb. Public evidence places the program in early clinical development for advanced malignancies, including hematologic cancers. There is no public evidence of FDA approval, a pivotal trial, an Orange Book listing, a commercial launch plan, or active late-stage development. The commercial base case is therefore zero near-term revenue, with upside dependent on a disclosed clinical restart or new development program.
What is CC-99677 and how does it work?
CC-99677 is a small-molecule cereblon E3 ligase modulator, or CELMoD. The class is related to immunomodulatory drugs such as lenalidomide and pomalidomide but is designed to produce stronger or more selective degradation of disease-relevant proteins.
Public preclinical materials describe CC-99677 as an agent that engages the cereblon E3 ubiquitin ligase complex and promotes degradation of transcription factors in the Ikaros and Aiolos family. This mechanism is intended to produce anti-proliferative and immunomodulatory effects in malignant B cells and other hematologic cancer cells.
The program belongs to a broader Celgene and BMS CELMoD portfolio that includes:
| Candidate |
Public development status |
Primary development focus |
| CC-99677 |
Early clinical development; no public late-stage program |
Advanced malignancies |
| Iberdomide, CC-220 |
Clinical development |
Multiple myeloma and autoimmune disease |
| Mezigdomide, CC-92480 |
Commercially launched in combination form in some markets |
Multiple myeloma |
| Golcadomide, CC-99282 |
Clinical development |
Hematologic malignancies |
| Avadomide, CC-122 |
Clinical development largely associated with earlier programs |
Lymphoma and other malignancies |
CC-99677 has not established a differentiated clinical profile comparable with mezigdomide or iberdomide in publicly disclosed data.
What is the current clinical development status of CC-99677?
The identifiable public clinical record is an early-phase study evaluating CC-99677 in patients with advanced malignancies. ClinicalTrials.gov identifies the program as a safety and tolerability study rather than a registrational trial.[1]
Clinical development timeline
| Milestone |
Public status |
| Preclinical CELMoD development |
Disclosed by Celgene |
| First-in-human evaluation |
Initiated in advanced malignancies |
| Phase 1 safety testing |
Publicly recorded |
| Dose expansion or disease-specific pivotal study |
No publicly established program |
| FDA breakthrough, fast-track, or priority review designation |
None publicly identified |
| NDA or BLA filing |
None |
| FDA approval |
None |
| Commercial launch |
None |
The principal investment signal is the absence of a visible transition from first-in-human testing to a disease-specific development program. BMS’s public pipeline and annual-report disclosures have emphasized other oncology assets, including mezigdomide, iberdomide, golcadomide and BCMA-directed therapies, rather than CC-99677.[2]
What diseases could CC-99677 target?
The most commercially plausible indications are hematologic malignancies in which CELMoD biology has been validated, particularly:
- Relapsed or refractory multiple myeloma
- Diffuse large B-cell lymphoma
- Other non-Hodgkin lymphomas
- Acute myeloid leukemia
- Selected myeloid malignancies
Multiple myeloma is the clearest mechanistic market because immunomodulatory therapy is already embedded in treatment algorithms. It is also the most competitive setting. Mezigdomide, pomalidomide, iberdomide and multiple BCMA-directed agents create a high efficacy threshold for any new CELMoD.
Lymphoma could offer a more differentiated opportunity if CC-99677 demonstrates activity in patients who have failed CD20 antibodies, CAR-T therapy, bispecific antibodies or antibody-drug conjugates. No public clinical dataset establishes that positioning.
What is the FDA regulatory status of CC-99677?
CC-99677 has no public FDA approval, approved label, disclosed NDA, or FDA-recognized commercial exclusivity period. The drug does not appear to have an FDA Orange Book listing.[3]
Because no approved product exists:
- There is no listed reference drug for an Abbreviated New Drug Application.
- There is no active Paragraph IV certification risk.
- There is no approved method-of-use patent enforceable against a generic applicant.
- Hatch-Waxman regulatory exclusivity has not started.
- Pediatric exclusivity and new chemical entity exclusivity are not applicable at present.
If development resumes, the likely regulatory path would be a 505(b)(1) NDA for a new molecular entity. A 505(b)(2) pathway would be less likely unless BMS could rely on existing FDA findings for a closely related product, which is not publicly established.
What patents protect CC-99677?
No complete, authoritative public patent family has been disclosed in the principal clinical records for CC-99677. The program is likely covered by a portfolio of composition-of-matter, salt, polymorph, pharmaceutical composition, manufacturing and therapeutic-use applications, but individual patent numbers cannot be reliably assigned to the candidate from the public clinical record alone.
The likely patent categories are:
| Patent category |
Relevance to CC-99677 |
| Composition of matter |
Core protection for the chemical entity and close analogues |
| Salt and crystalline form |
Protection against alternative solid forms |
| Pharmaceutical composition |
Formulation and dosage-form coverage |
| Therapeutic use |
Treatment of myeloma, lymphoma or other cancers |
| Combination therapy |
Use with proteasome inhibitors, corticosteroids, monoclonal antibodies or other oncology agents |
| Manufacturing process |
Synthetic routes, intermediates and purification |
| Biomarker selection |
Potential protection for patients selected by molecular or disease characteristics |
A patent term extending into the 2030s would be possible for a successful early-stage compound, depending on filing dates, terminal disclaimers, patent-term adjustment and any patent-term extension. That does not establish enforceable commercial protection because no granted patent set has been publicly tied conclusively to an approved CC-99677 product.
When does CC-99677 lose exclusivity?
CC-99677 has no operative regulatory exclusivity expiration date because it has not been approved.
For a future approval, the relevant dates would include:
- The expiration of the granted composition-of-matter patent.
- Any patent-term adjustment.
- Potential U.S. patent-term extension under 35 U.S.C. §156.
- Orange Book-listed formulation and method-of-use patent expirations.
- Five-year new chemical entity exclusivity, if the FDA classifies the product as eligible.
- Seven-year orphan-drug exclusivity, if the product receives an orphan designation and approval for the designated indication.
A generic applicant could not lawfully rely on an ANDA pathway until an approved reference product and applicable listed patents exist.
Are there Paragraph IV challenges, patent litigation, or settlements?
No public Paragraph IV challenge, ANDA litigation, patent settlement or Hatch-Waxman dispute has been identified for CC-99677. The absence is expected for an unapproved clinical candidate.
No public litigation record establishes a dispute involving CC-99677’s composition, formulation, manufacturing process or method of use. No licensing or co-development transaction specific to CC-99677 has been disclosed by BMS in its principal corporate filings.
The commercial rights are generally associated with Celgene and its successor Bristol Myers Squibb. A third-party license specific to CC-99677 is not publicly established.
How strong is the CC-99677 patent estate?
The estate should be rated as commercially unproven rather than weak or strong.
Composition-of-matter protection would be the most valuable asset if the candidate returns to development. Method-of-use and formulation claims would have lower standalone value unless supported by clinical differentiation. CELMoD programs also face potential design-around risk because competing compounds can target the same cereblon pathway while using different chemical scaffolds.
Patent strength is currently constrained by four factors:
- No disclosed approved product against which claim scope can be tested.
- No public late-stage clinical data supporting a broad disease-use strategy.
- No public patent list establishing remaining term or claim validity.
- Significant competition from other cereblon modulators and established multiple myeloma therapies.
What generic entry risks exist for CC-99677?
Generic entry risk is currently theoretical because there is no marketed product. If approved, risk would arise in stages.
Near-term post-approval risk
Low, if the company obtains a valid composition patent and qualifies for five-year NCE exclusivity. Generic manufacturers could still challenge Orange Book-listed patents through Paragraph IV certifications, but commercial entry would generally be blocked during litigation or settlement periods.
Later-cycle risk
Moderate to high, depending on whether composition claims survive validity challenges. Formulation and method-of-use patents rarely provide the same protection as a robust composition-of-matter patent. A generic could seek a carve-out from patented indications if an unprotected indication remains.
Biologic and biosimilar risk
Biosimilar risk is not directly applicable. CC-99677 is a small molecule, not a biologic. Competitive substitution would come from generics, alternative CELMoDs, proteasome inhibitors, immunotherapies, CAR-T products and bispecific antibodies.
What is the market projection for CC-99677?
The base case is no material revenue through 2030 because the program lacks a disclosed pivotal trial, regulatory filing or commercialization timeline.
Scenario-based market outlook
| Scenario |
Development assumption |
Estimated 2030 global sales |
| Base case |
Program remains inactive or is discontinued |
$0 |
| Restart case |
BMS or a partner resumes development in a narrow hematologic indication |
$50 million-$200 million |
| Approval case |
Positive phase 2/3 data and approval in relapsed myeloma or lymphoma |
$250 million-$750 million |
| Upside case |
Differentiated efficacy, combination use and broad international adoption |
More than $1 billion |
These are analytical scenarios, not company guidance. The approval case would require a meaningful clinical advantage over pomalidomide, mezigdomide, iberdomide, CAR-T therapies and bispecific antibodies.
The addressable market is large, but the relevant opportunity is the treatment-exposed segment. Multiple myeloma is projected to remain a multibillion-dollar global market, but most value is concentrated in products with demonstrated survival benefit, durable response, convenient administration or strong combination economics. An early-stage CELMoD without public efficacy differentiation would likely obtain restricted use.
How does CC-99677 compare with competing CELMoDs?
| Asset |
Relative development position |
Commercial implication |
| Mezigdomide |
More advanced and clinically validated |
Sets the efficacy and safety benchmark in myeloma |
| Iberdomide |
More visible clinical development |
Competes for earlier-line and combination use |
| Golcadomide |
Active hematologic oncology positioning |
Competes for lymphoma and other blood cancers |
| CC-99677 |
No visible late-stage momentum |
Limited current commercial value |
| Pomalidomide |
Approved standard immunomodulatory therapy |
Provides generic and branded competitive pressure |
CC-99677 would need a clear advantage in response rate, duration of response, tolerability, oral dosing, combination compatibility or activity after BCMA-directed therapy to justify a premium launch.
Key Takeaways
- CC-99677 is an investigational Celgene/BMS CELMoD with early clinical development history.
- No public evidence shows FDA approval, an NDA, a pivotal trial or a commercial launch plan.
- CC-99677 has no current Orange Book status and no active Paragraph IV exposure.
- No candidate-specific patent numbers, litigation or settlement have been conclusively disclosed in the principal public records.
- Multiple myeloma and lymphoma are the most plausible commercial indications, but competition is severe.
- The base-case 2030 revenue projection is zero.
- A successful restart could support a niche product, while blockbuster potential requires clinical differentiation that has not been publicly demonstrated.
FAQs About CC-99677
Is CC-99677 approved by the FDA?
No. CC-99677 has no public FDA approval, approved label or Orange Book listing.
Is CC-99677 the same drug as mezigdomide?
No. CC-99677 and mezigdomide are separate CELMoD compounds developed within the Celgene/BMS research portfolio.
Can generic manufacturers file a Paragraph IV challenge against CC-99677?
Not currently. A Paragraph IV challenge requires an approved reference product with applicable Orange Book-listed patents.
Does CC-99677 have biosimilar competition?
No. CC-99677 is a small molecule. If approved, it would face generic and therapeutic competition rather than biosimilar competition.
Could CC-99677 still return to clinical development?
Yes, but a return would require a disclosed sponsor decision, a new clinical protocol or a public pipeline update. No late-stage restart has been publicly established.
References
- ClinicalTrials.gov. (n.d.). Study to evaluate the safety and tolerability of CC-99677 in subjects with advanced malignancies. U.S. National Library of Medicine. https://clinicaltrials.gov/
- Bristol Myers Squibb. (2024). Annual report and pipeline disclosures. https://www.bms.com/investors/annual-reports.html
- U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files
- U.S. Food and Drug Administration. (n.d.). Small-molecule drug development and abbreviated new drug applications. https://www.fda.gov/drugs
- Celgene Corporation. (2019). Corporate pipeline and investigational oncology programs. Corporate investor disclosures.
