Cyclosporine

Generic Name: Cyclosporine

Brand Names: Cequa, Gengraf, Neoral, Restasis, Sandimmune, Verkazia, Vevye, Ikervis

Drug Type: Small Molecule

Chemical Formula: C_₆₂H_₁₁₁N_₁₁O_₁₂

CAS Number: 59865-13-3

Unique Ingredient Identifier: 83HN0GTJ6D

Background: Cyclosporine is a calcineurin inhibitor known for its immunomodulatory properties that prevent organ transplant rejection and treat various inflammatory and autoimmune conditions. It is isolated from the fungus Beauveria nivea. Initially manufactured by Sandoz and approved for use by the FDA in 1983, cyclosporine is now available in various products by Novartis (previously known as Sandoz).

Indication: Cyclosporine is approved for a variety of conditions. Firstly, it is approved for the prophylaxis of organ rejection in allogeneic kidney, liver, and heart transplants. It is also used to prevent bone marrow transplant rejection. For the above indications, cyclosporine can be used in conjunction with azathioprine and corticosteroids. Finally, cyclosporine can be used in patients who have chronic transplant rejection and have received previous immunosuppressive therapy and to prevent or treat graft-versus-host disease (GVHD).

Secondly, cyclosporine is used for the treatment of patients with severe active rheumatoid arthritis (RA) when they no longer respond to methotrexate alone. It can be used for the treatment of adult non-immunocompromised patients with severe, recalcitrant, plaque psoriasis that have failed to respond to at least one systemic therapy or when systemic therapies are not tolerated or contraindicated. The ophthalmic solution of cyclosporine is indicated to increase tear production in patients suffering from keratoconjunctivitis sicca. In addition, cyclosporine is approved for the treatment of steroid dependent and steroid-resistant nephrotic syndrome due to glomerular diseases which may include minimal change nephropathy, focal and segmental glomerulosclerosis or membranous glomerulonephritis.

A cyclosporine ophthalmic emulsion is indicated in the treatment of vernal keratoconjunctivitis in adults and children.

Off-label, cyclosporine is commonly used for the treatment of various autoimmune and inflammatory conditions such as atopic dermatitis, blistering disorders, ulcerative colitis, juvenile rheumatoid arthritis, uveitis, connective tissue diseases, as well as idiopathic thrombocytopenic purpura.

Associated Conditions: Atopic Dermatitis, Bone Marrow Transplant Rejection, Chronic transplant rejection, Connective Tissue Disorders, Dry Eyes, Graft-versus-host Disease (GVHD), Heart Transplant Rejection, Immune Thrombocytopenia (ITP), Interstitial Cystitis, Juvenile Idiopathic Arthritis (JIA), Kidney Transplant Rejection, Liver Transplant Rejection, Lupus Nephritis, Nephrotic Syndrome, Ocular Rosacea, Rheumatoid Arthritis, Severe Ulcerative Colitis, Steroid Dependent Nephrotic Syndrome, Steroid Resistant Nephrotic Syndrome, Uveitis, Vernal Keratoconjunctivitis, Blistering disorder, Refractory Ulcerative colitis, Severe Psoriasis, Severe, active Rheumatoid arthritis, Severe, recalcitrant Plaque psoriasis, Suppressed tear production

Clinical Trials

Fungal Ulcer Treatment Augmented With Natamycin and Cyclosporine A

Phase 3

Not yet recruiting

Conditions: Fungal Keratitis
Corneal Ulcer

Interventions: Drug: Cyclosporine A

First Posted Date: 2024-10-26

Last Posted Date: 2025-03-26

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 150

Registration Number: NCT06658002

Locations: 🇺🇸
University of California, San Farncisco, San Francisco, California, United States
🇮🇳
Aravind Eye Institute, Pondicherry, Tamil Nadu, India

A Phase II Study of Zuberitamab Injection in Patients With Primary Membranous Nephropathy

Phase 2

Not yet recruiting

Conditions: Primary Membranous Nephropathy

Interventions: Drug: Zuberitamab 600mg
Drug: Zuberitamab 1000mg
Drug: cyclosporine

First Posted Date: 2024-10-15

Last Posted Date: 2024-10-15

Lead Sponsor: BioRay Pharmaceutical Co., Ltd.

Target Recruit Count: 135

Registration Number: NCT06642909

Locations: 🇨🇳
Zhongshan Hospital Fudan University, Shanghai, Shanghai, China

A Study to Learn if the Study Medicines Called Itraconazole and Cyclosporine Change How the Body Processes the Other Study Medicine Called Danuglipron in Healthy Adults.

Phase 1

Active, not recruiting

Conditions: Healthy

Interventions: Drug: Danuglipron
Drug: Cyclosporine
Drug: Itraconazole

First Posted Date: 2024-08-07

Last Posted Date: 2025-03-28

Lead Sponsor: Pfizer

Target Recruit Count: 16

Registration Number: NCT06541678

Locations: 🇺🇸
Pfizer Clinical Research Unit - New Haven, New Haven, Connecticut, United States

Efficacy and Safety of rhTPO in Combination With Cyclosporine Versus Cyclosporine Alone in the Treatment of TD-NSAA

Phase 4

Not yet recruiting

Conditions: Aplastic Anemia
Transfusion-dependent Anemia

Interventions: Drug: rhTPO
Drug: Cyclosporin A

First Posted Date: 2024-07-29

Last Posted Date: 2024-07-29

Lead Sponsor: Peking Union Medical College Hospital

Target Recruit Count: 54

Registration Number: NCT06525948

Locations: 🇨🇳
Peking Union Medical College Hospital, Beijing, Beijing, China

a Retrospective Study on the Systemic Treatment of LPP and FFA

Completed

Conditions: Cicatricial Alopecia
Lichen Planopilaris
Lichen Plano-Pilaris
Frontal Fibrosing Alopecia
Hair Diseases
Scarring Alopecia
Hair Loss/Baldness

Interventions: Drug: Hydroxychloroquine
Drug: Methotrexate
Drug: Cyclosporine A
Drug: Retinoids

First Posted Date: 2024-07-22

Last Posted Date: 2024-07-22

Lead Sponsor: Erasmus Medical Center

Target Recruit Count: 315

Registration Number: NCT06512766

Locations: 🇳🇱
Erasmus MC, Rotterdam, Zuid-Holland, Netherlands

Dupilumab and House Dust Mite Immunotherapy in Patients With Atopic Dermatitis

Not Applicable

Completed

Conditions: Atopic Dermatitis

Interventions: Biological: tablets Acarizax
Biological: dupilumab
Drug: cyclosporine

First Posted Date: 2024-07-19

Last Posted Date: 2024-07-19

Lead Sponsor: Medical University of Silesia

Target Recruit Count: 132

Registration Number: NCT06509243

Locations: 🇵🇱
SUM, Zabrze, Poland

The COAT Trial: Cequa's Onset of Action Trial

Phase 4

Completed

Conditions: Dry Eye

Interventions: Drug: Cyclosporine ophthalmic solution

First Posted Date: 2024-07-01

Last Posted Date: 2024-07-01

Lead Sponsor: Research Insight LLC

Target Recruit Count: 52

Registration Number: NCT06482177

Locations: 🇺🇸
Harvard Eye Associates, Laguna Hills, California, United States

A Clinical Study of B007 in the Treatment of Primary Membranous Nephropathy.

Phase 2

Recruiting

Conditions: Primary Membranous Nephropathy

Interventions: Drug: B007
Drug: Cyclosporin Capsules

First Posted Date: 2024-06-24

Last Posted Date: 2025-03-25

Lead Sponsor: Shanghai Jiaolian Drug Research and Development Co., Ltd

Target Recruit Count: 216

Registration Number: NCT06470191

Locations: 🇨🇳
Beijing Tsinghua Changgung Hospital, Beijing, China
🇨🇳
The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
🇨🇳
Zhujiang Hospital of Southern Medical University, Guangzhou, China

and more 18 locations