CLINICAL TRIALS PROFILE FOR GENGRAF

All Clinical Trials for GENGRAF

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00008450 ↗	Total-Body Irradiation Followed By Cyclosporine and Mycophenolate Mofetil in Treating Patients With Severe Combined Immunodeficiency Undergoing Donor Bone Marrow Transplant	Completed	National Cancer Institute (NCI)	Phase 1	1997-08-11	This pilot clinical trial studies total-body irradiation followed by cyclosporine and mycophenolate mofetil in treating patients with severe combined immunodeficiency (SCID) undergoing donor bone marrow transplant. Giving total-body irradiation (TBI) before a donor bone marrow transplant using stem cells that closely match the patient's stem cells, helps stop the growth of abnormal cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may mix with the patient's immune cells and help destroy any remaining abnormal cells. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.
NCT00008450 ↗	Total-Body Irradiation Followed By Cyclosporine and Mycophenolate Mofetil in Treating Patients With Severe Combined Immunodeficiency Undergoing Donor Bone Marrow Transplant	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 1	1997-08-11	This pilot clinical trial studies total-body irradiation followed by cyclosporine and mycophenolate mofetil in treating patients with severe combined immunodeficiency (SCID) undergoing donor bone marrow transplant. Giving total-body irradiation (TBI) before a donor bone marrow transplant using stem cells that closely match the patient's stem cells, helps stop the growth of abnormal cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may mix with the patient's immune cells and help destroy any remaining abnormal cells. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.
NCT00008450 ↗	Total-Body Irradiation Followed By Cyclosporine and Mycophenolate Mofetil in Treating Patients With Severe Combined Immunodeficiency Undergoing Donor Bone Marrow Transplant	Completed	Fred Hutchinson Cancer Research Center	Phase 1	1997-08-11	This pilot clinical trial studies total-body irradiation followed by cyclosporine and mycophenolate mofetil in treating patients with severe combined immunodeficiency (SCID) undergoing donor bone marrow transplant. Giving total-body irradiation (TBI) before a donor bone marrow transplant using stem cells that closely match the patient's stem cells, helps stop the growth of abnormal cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may mix with the patient's immune cells and help destroy any remaining abnormal cells. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.
NCT00036738 ↗	Fludarabine Phosphate and Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate, D	Completed	National Cancer Institute (NCI)	Phase 2	2001-07-13	This phase II trial is studying how well fludarabine phosphate and total-body irradiation followed by donor peripheral blood stem cell transplant work in treating patients with acute lymphoblastic leukemia or chronic myelogenous leukemia that has responded to previous treatment with imatinib mesylate, dasatinib, or nilotinib. Giving low doses of chemotherapy, such as fludarabine phosphate, and total-body irradiation (TBI) before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving mycophenolate mofetil and cyclosporine after the transplant may stop this from happening.
NCT00036738 ↗	Fludarabine Phosphate and Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate, D	Completed	Fred Hutchinson Cancer Research Center	Phase 2	2001-07-13	This phase II trial is studying how well fludarabine phosphate and total-body irradiation followed by donor peripheral blood stem cell transplant work in treating patients with acute lymphoblastic leukemia or chronic myelogenous leukemia that has responded to previous treatment with imatinib mesylate, dasatinib, or nilotinib. Giving low doses of chemotherapy, such as fludarabine phosphate, and total-body irradiation (TBI) before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving mycophenolate mofetil and cyclosporine after the transplant may stop this from happening.
NCT00057954 ↗	Reduced-Intensity Regimen Before Allogeneic Transplant for Patients With Relapsed Non-Hodgkin's or Hodgkin's Lymphoma	Terminated	National Cancer Institute (NCI)	Phase 2	2005-06-01	RATIONALE: Photopheresis allows patient white blood cells to be treated with ultraviolet (UV) light and drugs outside the body to inactivate T cells. Pentostatin may suppress the immune system and reduce the chance of developing graft-versus-host disease (GVHD) following bone marrow transplantation. Combining photopheresis with pentostatin and total-body irradiation may be effective in killing cancer cells before bone marrow transplantation. PURPOSE: This phase II trial is studying how well giving photophoresis together with pentostatin and total-body irradiation as a reduced-intensity regimen before allogeneic bone marrow transplantation works in treating patients with relapsed non-Hodgkin's or Hodgkin's lymphoma.
NCT00057954 ↗	Reduced-Intensity Regimen Before Allogeneic Transplant for Patients With Relapsed Non-Hodgkin's or Hodgkin's Lymphoma	Terminated	Eastern Cooperative Oncology Group	Phase 2	2005-06-01	RATIONALE: Photopheresis allows patient white blood cells to be treated with ultraviolet (UV) light and drugs outside the body to inactivate T cells. Pentostatin may suppress the immune system and reduce the chance of developing graft-versus-host disease (GVHD) following bone marrow transplantation. Combining photopheresis with pentostatin and total-body irradiation may be effective in killing cancer cells before bone marrow transplantation. PURPOSE: This phase II trial is studying how well giving photophoresis together with pentostatin and total-body irradiation as a reduced-intensity regimen before allogeneic bone marrow transplantation works in treating patients with relapsed non-Hodgkin's or Hodgkin's lymphoma.

Clinical Trial Conditions for GENGRAF

Condition Name

Condition Name for GENGRAF
Intervention	Trials
Myelodysplastic Syndrome	10
Acute Myeloid Leukemia	9
Acute Lymphoblastic Leukemia	8
Prolymphocytic Leukemia	7

Condition MeSH

Condition MeSH for GENGRAF
Intervention	Trials
Leukemia	20
Leukemia, Myeloid	17
Leukemia, Myeloid, Acute	15
Myelodysplastic Syndromes	15

Clinical Trial Locations for GENGRAF

Trials by Country

Trials by Country for GENGRAF
Location	Trials
United States	151
Canada	6
Denmark	3
China	1
Malaysia	1

Trials by US State

Trials by US State for GENGRAF
Location	Trials
Washington	24
Colorado	11
Ohio	6
Texas	6
California	6

Clinical Trial Progress for GENGRAF

Clinical Trial Phase

Clinical Trial Phase for GENGRAF
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for GENGRAF
Clinical Trial Phase	Trials
Completed	20
Recruiting	10
Terminated	4

Clinical Trial Sponsors for GENGRAF

Sponsor Name

Sponsor Name for GENGRAF
Sponsor	Trials
National Cancer Institute (NCI)	31
Fred Hutchinson Cancer Research Center	21
National Heart, Lung, and Blood Institute (NHLBI)	6

Sponsor Type

Sponsor Type for GENGRAF
Sponsor	Trials
Other	42
NIH	38
Industry	3

Gengraf (cyclosporine) Clinical Trials Update, Market Analysis, and Exclusivity/IP Outlook (2026)

Last updated: May 20, 2026

Gengraf is an oral cyclosporine product (modified formulation) used for prevention of organ-transplant rejection and is not a new-drug launch story. The business focus in 2026 is continued demand stability, generic and authorized generic pressure, and the remaining headroom from brand-specific reimbursement and channel mix rather than near-term patent-driven pricing power.

This update does not provide clinical-trial outcome projections beyond what is supported by filed/updated public records for Gengraf’s current indications and supply chain position.

What is the latest clinical trials status for Gengraf (cyclosporine) in 2026?

Featured snippet answer: Gengraf’s public clinical-development footprint is limited in 2024–2026 compared with newer immunosuppressants; updates typically track post-approval studies, pharmacokinetics, and real-world evidence rather than late-stage Phase 3 programs.

Are there new Phase 3 or pivotal studies for Gengraf?

Public registries for Gengraf have historically shown fewer pivotal trials than for newer cyclosporine brands and alternatives (tacrolimus-based regimens). In practice, Gengraf’s clinical updates most often relate to:

• Pharmacokinetic comparisons (exposure variability, food effects, switching stability)
• Safety follow-ups in transplant cohorts
• Study updates that report endpoints like acute rejection rates, graft survival, and renal function trajectories

What endpoints matter most in cyclosporine transplant studies?

Trials and registry studies for cyclosporine products typically weight:

• Acute rejection incidence (biopsy-proven)
• Graft survival and patient survival
• Nephrotoxicity markers (serum creatinine trends)
• Cyclosporine exposure metrics (C2 levels for modern monitoring approaches)

What has changed clinically since cyclosporine was introduced?

Clinical practice has shifted toward tighter therapeutic drug monitoring and more standardized regimens (steroids plus an antimetabolite background, typically mycophenolate). That reduces variability but does not eliminate intolerance or rejection risks, which keeps market demand durable but price-sensitive.

How big is the Gengraf market and what share does it hold in cyclosporine transplant immunosuppression?

Featured snippet answer: Gengraf sits in a mature, competitive segment within oral cyclosporine immunosuppression. Market value is driven by transplant volumes, adherence to cyclosporine due to tolerability and payer preferences, and generic availability.

Market structure: brand, authorized generic, and generic cyclosporine

In oral cyclosporine, the competitive set typically includes:

• Other cyclosporine oral products (including modified and non-modified formulations depending on region)
• Generic cyclosporine products at materially lower net prices
• Tacrolimus-based regimens that compete clinically for some patient segments

Demand drivers

Key demand signals for Gengraf include:

• Kidney transplant prevalence and incident transplant volumes
• Conversion patterns among stable patients (switching barriers due to exposure monitoring)
• Payer formulary decisions and prior authorization requirements
• Coverage for brand modified formulations when generic products have narrower therapeutic equivalence tolerance in clinical practice

When do Gengraf exclusivity rights expire, and what does that mean for generic entry risk?

Featured snippet answer: For mature brands like Gengraf, the generic threat is not “incoming.” The main question is whether any remaining listed Orange Book exclusivities or formulation/patent barriers extend launch timelines for specific dosage strengths or switching pathways.

How to read the exclusivity picture for mature immunosuppressants

For cyclosporine products, launch risk can be driven by:

• Patent expirations covering formulation, manufacturing, or therapeutic claims
• Exclusivity carve-outs by dosage form strength
• Orange Book-listed method-of-use and formulation patents

What is the practical generic entry risk in 2026?

By 2026, generic encroachment in cyclosporine is usually already present for many strengths. Incremental risk typically comes from:

• Additional ANDA approvals by competitors
• Shelf access changes (distributor and hospital procurement contracts)
• Litigation outcomes that unlock specific strengths or “skinny labels” in particular indications

What patents protect Gengraf, and how strong is the patent estate?

Featured snippet answer: Gengraf’s patent estate is usually mature and dominated by formulation and method-of-use protections that often lapse or have been litigated long before 2026. The strength today is more about whether any late-expiring listed patents remain for specific strengths or indications.

How Gengraf patent protection typically breaks down

Patent estates for cyclosporine brands generally split into:

• Formulation patents (modified release/exposure characteristics, composition)
• Method-of-use patents (transplant rejection prevention regimens)
• Process/manufacturing patents

Actionability for business teams

If any listed patents remain, they matter most for:

• Filing strategy for Paragraph IV applicants
• Settlement leverage
• Potential product switch restrictions in formularies and contracts

What Orange Book status does Gengraf have, and which products are its closest generic competitors?

Featured snippet answer: Orange Book status for Gengraf determines which ANDA applicants face listed patent and exclusivity barriers. Closest competitors are usually ANDA-labeled cyclosporine modified oral products that are substitutable at the dosage-strength level.

What “Orange Book status” impacts operationally

Orange Book listings drive:

• Timing of FDA approval and labeling carve-outs
• Patent certification routes (Paragraph II, III, IV)
• Settlement or design-around opportunities (strength-by-strength)

Closest-competition lens

Business comparisons should focus on:

• Net price gap versus brand
• Formulary acceptance
• Patient switching patterns and monitoring burden

What patent litigation affects Gengraf, including Paragraph IV challenges and settlements?

Featured snippet answer: For legacy cyclosporine brands, litigation risk is concentrated in earlier ANDA years; in 2026, the question is whether any ongoing cases still block specific strengths or label language.

Litigation categories to map

When assessing litigation impact on Gengraf:

• Paragraph IV ANDA filings alleging non-infringement or invalidity of listed patents
• Injunction/temporary restraining order dynamics
• Consent judgments and settlement-driven launch timing

Commercial impact of litigation outcomes

Even without new filings, litigation outcomes can change:

• Launch sequence across strengths
• Competitive intensity in hospital formularies
• Net pricing due to entry timing

How does Gengraf compare with other cyclosporine and tacrolimus immunosuppressants on market and clinical positioning?

Featured snippet answer: Tacrolimus-based regimens often compete for kidney transplant immunosuppression share due to efficacy and clinician familiarity, while Gengraf retains a niche where cyclosporine tolerability, switching stability, and payer coverage drive use.

Key differentiation that matters commercially

• Therapeutic drug monitoring practices and perceived exposure stability
• Patient history and switching resistance
• Payer formulary tiering versus tacrolimus alternatives

Where Gengraf likely holds share

Gengraf is most likely to maintain volume when:

• Patients are stable on cyclosporine and switching is avoided
• Hospitals or regions have procurement contracts that include brand modified cyclosporine products
• Payers prefer cost-effective regimens but accept cyclosporine alternatives when monitoring is established

What are the formulation and dosing considerations that shape reimbursement and switching?

Featured snippet answer: Dosing strengths and patient monitoring requirements shape real-world substitution risk between brand and generic cyclosporine products, which affects net sales durability.

Dose-strength and adherence mechanics

Switching from one cyclosporine product to another can trigger:

• Different absorption/exposure profiles
• Monitoring intensification and dose adjustment periods
• Provider and payer concern about exposure consistency

How that affects generic penetration

Generic uptake can slow when:

• Clinicians insist on “same product” stability for stable patients
• Monitoring protocols are burdensome or require more frequent lab visits
• Payers restrict substitution for certain patient cohorts

What regulatory status does Gengraf have with FDA, and what labeling constraints matter for competitors?

Featured snippet answer: Gengraf is approved for transplant-related immunosuppression under existing FDA labeling; competitor approvals depend on matching active ingredient/formulation and meeting bioequivalence and labeling requirements.

Which regulatory items drive entry

For ANDAs/alternatives, the main constraints are:

• Bioequivalence for the modified cyclosporine formulation
• Labeling consistency for indications and dosing instructions
• Drug product manufacturing controls and stability

How many patients use Gengraf, and what revenue trajectory should investors model?

Featured snippet answer: Gengraf revenue trajectory in 2026 should be modeled as mature-brand dynamics: transplant volume growth minus price erosion from generics, offset by stable patient cohorts and payer-specific contracting.

Projection framework (how to model, not what to guess)

For a mature immunosuppressant, a robust model decomposes revenue into:

• Transplant incidence and prevalence growth (volume)
• Brand-to-generic mix (share shift)
• Net price trajectory (gross-to-net compression and rebates)
• Strength-level penetration and substitution rates
• Channel mix (hospital procurement versus retail)

What typically happens next for cyclosporine brands

• Net price continues to trend down toward a competitive equilibrium
• Remaining brand share persists in stable cohorts
• Any additional launches by generics accelerate share loss more than they reduce demand

What are the main commercial risks to Gengraf in the next 12–24 months?

Featured snippet answer: Risks are dominated by generic mix shifts, payer formulary revisions, and competitive substitution toward tacrolimus-based regimens and other immunosuppressive combinations.

Risk list that affects quarterly sales

• Additional ANDA approvals or broad generic switching on key strengths
• Formulary tier movement or prior authorization tightening
• Clinical practice preference shifts in kidney transplant protocols
• Supply chain disruptions at branded or generic manufacturing sites

Key Takeaways

• Gengraf remains a mature cyclosporine immunosuppressant with clinical use anchored in transplant rejection prevention and monitoring-based dosing stability.
• In 2026, the competitive story is generic mix and payer contracting rather than new pivotal clinical development.
• Patent and Orange Book effects are likely focused on any remaining listed patents/exclusivities by strength and label scope, which drive launch timing rather than changing clinical demand.
• Market projections should use a volume-share-price decomposition reflecting ongoing price erosion and stable use in switched-resistant cohorts.

FAQs

1) Is Gengraf being studied in new transplant indications?

No broad new indication expansion is typically visible for legacy cyclosporine brands; updates generally focus on monitoring, exposure, and safety follow-through.

2) How does therapeutic drug monitoring affect Gengraf switching to generics?

It increases clinical caution around product interchangeability, which can slow substitution among stable patients and maintain some brand share.

3) Do tacrolimus regimens reduce Gengraf demand in kidney transplant patients?

They can. Tacrolimus-based regimens compete for standard-of-care share, but cyclosporine persists in segments where stability and tolerability drive persistence.

4) What do Paragraph IV filings mean for Gengraf shareholders?

They change the probability and timing of additional generic launches for specific strengths/labels, affecting net pricing and share.

5) Which dosing strengths tend to be most exposed to generic substitution?

Strengths with broader ANDA coverage and fewer switching restrictions are typically most exposed, since payer substitution policies and clinician habits drive uptake.

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References

No sources were cited because the necessary public record set (FDA Orange Book entries for each strength, current exclusivity/patent lists, active ANDA litigation dockets, and registry status updates) was not provided in the prompt.