Who are FKS518's main competitors?

Direct comparators (same drug class / molecular target / therapeutic area): Elidel, Prograf, Sandimmune, Sandimmune, CYCLOSPORINE, Cyclosporine (Neoral).

How often does this brief refresh?

Every 30 minutes from primary sources (FDA, EMA, MHRA, PMDA, ClinicalTrials.gov, USPTO). Subscribe to the RSS feed below for push alerts.

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Last reviewed 2026-05-13 · How we verify

FKS518 — Competitive Intelligence Brief

FKS518 (FKS518) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Calcineurin inhibitor. Area: Immunology.

phase 3 Calcineurin inhibitor Calcineurin (via FKBP12 binding) Immunology Small molecule Live · refreshed every 30 min

Target snapshot

FKS518 (FKS518) — Fresenius Kabi SwissBioSim GmbH. FKS518 is a calcineurin inhibitor that suppresses T-cell activation by blocking the phosphatase calcineurin, thereby reducing immune-mediated rejection.

Comparator set (6 drugs)

Auto-detected by same drug class / molecular target / therapeutic area, ranked by phase + recency. Override with ?vs=slug1,slug2,….

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
FKS518 TARGET	FKS518	Fresenius Kabi SwissBioSim GmbH	phase 3	Calcineurin inhibitor	Calcineurin (via FKBP12 binding)
Elidel	PIMECROLIMUS	Bausch Health	marketed	Calcineurin Inhibitor Immunosuppressant [EPC]	Peptidyl-prolyl cis-trans isomerase FKBP1A	2001-01-01
Prograf	TACROLIMUS	Astellas Pharma	marketed	Calcineurin Inhibitor Immunosuppressant	Interferon gamma	1994-01-01
Sandimmune	cyclosporine	Novartis AG (originally Sandoz)	marketed	Calcineurin inhibitor (immunosuppressant)	Calcineurin subunit B type 1, Canalicular multispecific organic anion transporter 1, Canalicular multispecific organic anion transporter 2	1983-11-14
Sandimmune	Ciclosporin	Novartis	marketed	Calcineurin Inhibitor Immunosuppressant [EPC]	Serine/threonine-protein phosphatase 2B catalytic subunit alpha isoform	1983-01-01
CYCLOSPORINE	CYCLOSPORINE		marketed	Calcineurin Inhibitor Immunosuppressant [EPC]	calcineurin	1983-01-01
Cyclosporine (Neoral)	Cyclosporine (Neoral)	Novartis	marketed	Calcineurin inhibitor	Calcineurin (via cyclophilin binding)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

2027-11-03 — Sandimmune · 8298568 · Formulation · US
2027-11-03 — Sandimmune · 8298568 · US
2028-05-30 — Prograf · 9549918 · Formulation · US
2028-05-30 — Prograf · 10166190 · Formulation · US
2028-05-30 — Prograf · 11419823 · Formulation · US
2028-05-30 — Prograf · 12403095 · Formulation · US
2028-05-30 — Prograf · 11123331 · Method of Use · US
2028-05-30 — Prograf · 11110081 · Method of Use · US
2028-05-30 — Prograf · 12083103 · Method of Use · US
2028-05-30 — Prograf · 10864199 · Method of Use · US
2028-08-30 — Prograf · 8664239 · Method of Use · US
2028-08-30 — Prograf · 8685998 · Formulation · US
2029-06-02 — Sandimmune · 9132071 · US
2029-06-02 — Sandimmune · 9132071 · Formulation · US
2030-12-13 — Sandimmune · 8614178 · US
2030-12-13 — Sandimmune · 8614178 · Formulation · US
2031-02-25 — Sandimmune · 8292129 · Formulation · US
2031-02-25 — Sandimmune · 8292129 · US
2032-04-16 — Sandimmune · 8561859 · US
2032-04-16 — Sandimmune · 8561859 · Formulation · US
2033-08-23 — Sandimmune · 9937225 · US
2033-08-23 — Sandimmune · 8980839 · US
2033-08-23 — Sandimmune · 10441630 · US
2033-08-23 — Sandimmune · 8980839 · Formulation · US
2033-08-23 — Sandimmune · 9937225 · Formulation · US
2033-08-23 — Sandimmune · 10441630 · Formulation · US
2034-02-07 — Sandimmune · 9676525 · US
2034-02-07 — Sandimmune · 9676525 · Formulation · US
2034-05-11 — Sandimmune · 9669974 · Formulation · US
2034-05-11 — Sandimmune · 9669974 · US

Sponsor landscape (Calcineurin inhibitor class)

Novartis · 4 drugs in this class
Astellas Pharma Inc · 4 drugs in this class
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. · 4 drugs in this class
University of Cincinnati · 3 drugs in this class
Allergan · 3 drugs in this class
Astellas Pharma China, Inc. · 3 drugs in this class
Novaliq GmbH · 3 drugs in this class
Hoffmann-La Roche · 3 drugs in this class
LEO Pharma · 3 drugs in this class
Santen SAS · 3 drugs in this class

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Cite this brief

Drug Landscape (2026). FKS518 — Competitive Intelligence Brief. https://druglandscape.com/ci/fks518. Accessed 2026-05-13.

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