CLINICAL TRIALS PROFILE FOR ZINBRYTA

All Clinical Trials for ZINBRYTA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00246129 ↗	CamTac Trial:Campath-Tacrolimus vs IL2R MoAb/Tacrolimus/MMF in Renal Transplantation	Completed	EMagnusson	Phase 4	2005-10-01	The advent of new, potent immunosuppressive (anti-rejection) drugs over the past ten years has substantially reduced the risk of rejection after kidney transplantation, has allowed the development of immuno-suppressive regimens that do not use long-term steroids (steroid avoidance), and has improved transplant success rates both in the short and medium term. The main new agents used in these modern regimens are the calcineurin inhibitor (CNI) tacrolimus; the anti-proliferative agent mycophenolate; and induction agents which are used to provide effective early suppression of the rejection process; these include monoclonal antibodies (MoAb) such as IL-2 receptor blocking antibodies (IL-2R MoAb: basiliximab and daclizumab) and the anti-CD52 antibody Campath-1H (alemtuzumab). Although almost all modern immunosuppressive regimens involve one or more of these agents, it is not known which is the safest and most effective combination. This randomised controlled trial compares two steroid sparing regimens which have been used with very good short and medium term results at St Mary's Hospital Renal and Transplant Unit over the last 5 years. The primary hypothesis is that the alemtuzumab/tacrolimus regimen is as effective and safe as the IL-2R MoAb/tacrolimus/mycophenolate regimen.
NCT00246129 ↗	CamTac Trial:Campath-Tacrolimus vs IL2R MoAb/Tacrolimus/MMF in Renal Transplantation	Completed	Hammersmith Hospitals NHS Trust	Phase 4	2005-10-01	The advent of new, potent immunosuppressive (anti-rejection) drugs over the past ten years has substantially reduced the risk of rejection after kidney transplantation, has allowed the development of immuno-suppressive regimens that do not use long-term steroids (steroid avoidance), and has improved transplant success rates both in the short and medium term. The main new agents used in these modern regimens are the calcineurin inhibitor (CNI) tacrolimus; the anti-proliferative agent mycophenolate; and induction agents which are used to provide effective early suppression of the rejection process; these include monoclonal antibodies (MoAb) such as IL-2 receptor blocking antibodies (IL-2R MoAb: basiliximab and daclizumab) and the anti-CD52 antibody Campath-1H (alemtuzumab). Although almost all modern immunosuppressive regimens involve one or more of these agents, it is not known which is the safest and most effective combination. This randomised controlled trial compares two steroid sparing regimens which have been used with very good short and medium term results at St Mary's Hospital Renal and Transplant Unit over the last 5 years. The primary hypothesis is that the alemtuzumab/tacrolimus regimen is as effective and safe as the IL-2R MoAb/tacrolimus/mycophenolate regimen.
NCT02881567 ↗	Efficacy and Safety of Daclizumab in Participants With RRMS Switching From Natalizumab	Terminated	AbbVie	Phase 3	2017-04-18	The primary objective of the study is to evaluate the effects of treatment with daclizumab on the proportion of participants relapse-free at 6 months in Relapsing-Remitting Multiple Sclerosis (RRMS) participants, who switched from treatment with natalizumab to daclizumab due to safety concerns. The secondary objectives of this study in this study population are to evaluate the effects of daclizumab on the following: 1) Multiple Sclerosis (MS) relapse activity including the annualized relapse rate (ARR) and the proportion of participants experiencing relapses requiring hospitalization and/or steroid treatment; 2) MS-related outcomes measured using magnetic resonance imaging (MRI); 3) Safety and tolerability in participants previously treated with natalizumab.
NCT02881567 ↗	Efficacy and Safety of Daclizumab in Participants With RRMS Switching From Natalizumab	Terminated	Biogen	Phase 3	2017-04-18	The primary objective of the study is to evaluate the effects of treatment with daclizumab on the proportion of participants relapse-free at 6 months in Relapsing-Remitting Multiple Sclerosis (RRMS) participants, who switched from treatment with natalizumab to daclizumab due to safety concerns. The secondary objectives of this study in this study population are to evaluate the effects of daclizumab on the following: 1) Multiple Sclerosis (MS) relapse activity including the annualized relapse rate (ARR) and the proportion of participants experiencing relapses requiring hospitalization and/or steroid treatment; 2) MS-related outcomes measured using magnetic resonance imaging (MRI); 3) Safety and tolerability in participants previously treated with natalizumab.

Clinical Trial Conditions for ZINBRYTA

Condition Name

Condition Name for ZINBRYTA
Intervention	Trials
Kidney Diseases	1
Kidney Failure	1
Kidney Transplantation	1
Relapsing-Remitting Multiple Sclerosis (RRMS)	1

Condition MeSH

Condition MeSH for ZINBRYTA
Intervention	Trials
Multiple Sclerosis	1
Renal Insufficiency	1
Kidney Diseases	1
Sclerosis	1

Clinical Trial Locations for ZINBRYTA

Trials by Country

Trials by Country for ZINBRYTA
Location	Trials
Germany	4
United States	3
Italy	2
Canada	1
United Kingdom	1

Trials by US State

Trials by US State for ZINBRYTA
Location	Trials
Wisconsin	1
Iowa	1
Florida	1

Clinical Trial Progress for ZINBRYTA

Clinical Trial Phase

Clinical Trial Phase for ZINBRYTA
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1

Clinical Trial Status

Clinical Trial Status for ZINBRYTA
Clinical Trial Phase	Trials
Completed	1
Terminated	1

Clinical Trial Sponsors for ZINBRYTA

Sponsor Name

Sponsor Name for ZINBRYTA
Sponsor	Trials
EMagnusson	1
Hammersmith Hospitals NHS Trust	1
AbbVie	1

Sponsor Type

Sponsor Type for ZINBRYTA
Sponsor	Trials
Other	2
Industry	2

ZINBRYTA Market Analysis and Financial Projection

Last updated: April 25, 2026

ZINBRYTA (daclizumab): What’s the Current Clinical and Market Picture?

ZINBRYTA (daclizumab) is not an ongoing, commercially scaling brand. The product’s market and clinical footprint shifted after regulatory actions that culminated in withdrawal decisions and termination of development-related programs in multiple geographies. As a result, “clinical trials update” and “market projection” are best framed as a status assessment: no active late-stage pipeline tailwind and a shrinking addressable market rather than growth.

What happened to ZINBRYTA’s clinical program after safety actions?

Key regulatory and access milestones

• FDA review and authorization ended in a restricted trajectory: ZINBRYTA was approved for relapsing forms of multiple sclerosis but later became the subject of safety concerns, including serious immune-mediated adverse events.
• FDA action: In March 2018, Biogen voluntarily withdrew ZINBRYTA from the U.S. market following confirmed serious safety risks. (FDA actions and company withdrawal were reported based on the safety profile and regulatory posture.)
• European Union action: In the EU, EMA recommended suspension/withdrawal measures tied to safety findings, with the product eventually withdrawn from European markets.

Trial activity status

• The practical clinical-trials conclusion for ZINBRYTA is that the program did not maintain an ongoing, competitive late-stage development track comparable to mainstream MS assets.
• Post-withdrawal, the trial ecosystem shifted toward:
  • Safety follow-up and long-term observation tied to prior exposure
  • Administrative closure of interventional programs rather than new efficacy expansion

Net result: ZINBRYTA does not currently behave like an “active trial” franchise. Its clinical footprint is dominated by post-market safety follow-on rather than new confirmatory studies.

How does ZINBRYTA’s market position look post-withdrawal?

U.S. market

• Withdrawal: Biogen’s March 2018 withdrawal ended new U.S. patient starts and materially reduced sales velocity.
• Commercial state after withdrawal: Post-withdrawal, the remaining market is limited to:
  • Potentially residual supply from prior channels (short-lived in practice)
  • Incidental use in managed settings only if any remaining access existed, which did not create sustained demand

EU and rest-of-world access

• EU suspension/withdrawal: EMA-driven actions resulted in loss of EU marketing authorization.
• Global implication: Without authorization and with commercial withdrawal, the addressable market collapses to historical demand and any narrow residual access patterns before full removal.

Competitive MS landscape impact

Even when ZINBRYTA was active, it competed in a crowded MS biologics and disease-modifying therapy environment. Post-withdrawal:

• Market share did not revert to ZINBRYTA because the product is no longer broadly available
• Patients migrated to other MS immunotherapies and immune-modulating agents that maintained access

What market projection is supportable for ZINBRYTA?

Projection logic

With U.S. withdrawal and EU/EMA withdrawal/suspension, any “forecast” becomes a projection of absence, not expansion. The only plausible forward-looking outcomes are:

• Zero or near-zero incremental revenue from new patient starts in major regulated markets
• No meaningful trajectory recovery through additional launches because marketing authorizations were removed/suspended and the sponsor’s commercialization ended

Directional projection (qualitative)

• Revenue trend: Down to near-zero following withdrawal, with no credible base for rebound
• Share trend: Zero competitive share going forward in authorized markets
• Patient starts: None in major markets after withdrawal timelines

Net result: A rational business projection is that ZINBRYTA remains effectively at end-of-commercialization status rather than entering a growth or re-entry phase absent a regulatory revival, which did not occur in the mainstream market framework.

Where does ZINBRYTA’s regulatory status sit today?

United States

• FDA approval existed historically, but Biogen withdrew the product from the market after safety issues. (FDA communications and company statements in 2018 describe the withdrawal.) [1]

European Union

• EMA review identified serious safety risks and led to regulatory action including suspension/withdrawal from EU markets. (EMA communications describe the action.) [2]

What safety and risk factors drove the withdrawal decisions?

The withdrawal actions were linked to serious immune-mediated risks observed in the post-authorization setting, including:

• Severe immune-mediated adverse events
• Other serious complications that caused regulators to treat the benefit-risk balance as unfavorable in the broader population

These risks were central to regulatory and sponsor decisions, and they displaced the product from routine clinical use pathways in major markets.

What does the clinical evidence base imply for future development?

ZINBRYTA’s core efficacy evidence (historically) supported its approval in relapsing MS, but the safety profile became the limiting factor. Post-withdrawal, the development posture moved away from competitive expansion because:

• Regulatory authorization was removed or suspended in principal jurisdictions
• New patient access pathways were not reopened through a fresh, positive benefit-risk recalibration

For business and investment decisions, this means:

• No scalable pipeline probability tied to ongoing, late-stage MS trials for ZINBRYTA
• No credible re-launch mechanism implied by the withdrawal sequence

Operational implications for MS R&D and investment screens

If you screen immunology/biologic MS assets for reinvigorating market potential, ZINBRYTA behaves like a case-closed example:

• Clinical: safety follow-up dominates rather than new confirmatory launches
• Commercial: withdrawal ends revenue generation, removing it from near-term market models
• Regulatory: authority-driven removal reduces probability of near-term re-entry

Key Takeaways

• ZINBRYTA’s clinical and market trajectory ended for routine use after major safety concerns.
• Biogen withdrew ZINBRYTA from the U.S. market in March 2018, and EMA actions resulted in suspension/withdrawal in the EU.
• Forward-looking market projection is effectively near-zero incremental revenue and no competitive share in authorized markets.
• ZINBRYTA is best treated as a terminated commercialization and closed clinical development track, with any remaining activity confined to safety follow-up and administrative closure.

FAQs

1) Is ZINBRYTA currently authorized for MS treatment in the U.S.?

No. Biogen withdrew ZINBRYTA from the U.S. market in March 2018 after safety concerns. [1]

2) Is ZINBRYTA available in Europe?

Regulatory actions in the EU led to suspension/withdrawal outcomes tied to safety findings. [2]

3) Are there any new late-stage ZINBRYTA efficacy trials driving a revival?

The post-withdrawal posture is dominated by safety-related follow-up and program closure rather than new late-stage efficacy expansion.

4) What does this mean for revenue projections?

A credible projection model treats incremental revenue as near-zero due to lack of authorized market access and completed withdrawal steps. [1,2]

5) What was the core reason regulators acted?

Serious safety risks after authorization shifted the benefit-risk balance unfavorably, driving FDA and EMA actions. [1,2]

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References

[1] U.S. Food and Drug Administration. (2018). FDA statement on the voluntary withdrawal of ZINBRYTA (daclizumab) from the U.S. market.
[2] European Medicines Agency. (2018). EMA recommendations/actions related to daclizumab (ZINBRYTA) in the European Union following safety concerns.