ClinicalTrials.gg
Drug

Tacrolimus clinical trials

Also written Prograf, FK506, Advagraf and Fujimycin.

studies test it
600
open now
52
in phase 3
110
first study started
1998

How each study uses Tacrolimus is sorted by a rule, right about nine times in ten. Readers can ask us to read every study one by one.Ask us to read each study

Get an email when these change. Save the Tacrolimus studies recruiting or about to start — once a week, free: studies that open, close, add sites or post results.

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Example · made-up studies

Breast cancer · Recruiting: 2 came in, 3 changed

What changed in your saved searches, Oct 31 – Nov 6:

A study of drug A after surgery for early breast cancer

Came in · now Recruiting

Drug B with hormone therapy in advanced breast cancer

Changed

· Sites: 4 added, including Seoul and Busan

· Enrollment: 300 → 450 participants

Exercise during chemotherapy

Now Active, not recruiting

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Approvals

The first approval found in each region, with its record

United States
8 Apr 1994 · PROGRAF · NDA 050708 (FDA, Drugs@FDA)
European Union
27 Feb 2002 · Protopic · EMEA/H/C/000374 (EMA)

From FDA's Drugs@FDA and Purple Book (through openFDA) and the European Medicines Agency, files of Sept 2026 and 27 Oct 2026. National approvals in Europe and other countries are not included. How this is worked out

How studies write it

Studies that test it under each name

Name

Tacrolimus
366
Hecoria
25
tacrolimus ointment
20
Envarsus
19
MR4
16

Brand

Prograf
162
Advagraf
57
Protopic
51
Envarsus XR
17
Modigraf
4

Development codes

FK506
112
FK506E
14
FK506MR
5
FK506XL
3
VI-0106
1
FR-900506
1

Other names

Fujimycin
35
tacro
1

In one entry with another drug

Given together, or one or the other

tacrolimus and mycophenolate mofetil
2
Tacrolimus+mycophenolate mofetil
2
Cyclosporine or tacrolimus
2
Tacrolimus and MMF
2
sirolimus, cyclosporine, tacrolimus
2

Studies by the year they started

588 studies that test it; most in 2004 (35)

Studies that test Tacrolimus, by start year
YearStudies
19982
19994
20008
20017
200223
200322
200435
200525
200629
200725
200831
200923
201032
201132
201224
201325
201420
201528
201623
201726
201824
201923
202023
20219
202214
202311
202413
202511
202616

By phase

A phase 1/2 study counts in both.

Early Phase 1
11
Phase 1
74
Phase 2
205
Phase 3
110
Phase 4
194
No phase
50

What it is tested for

Each study’s main condition, where its own words name it, so a study counts once.

Who runs them

Industry 175 · Other 425

Astellas Pharma Inc (83) · Fred Hutchinson Cancer Center (18) · Veloxis Pharmaceuticals (11) · National Institute of Allergy and Infectious Diseases (NIAID) (10) · M.D. Anderson Cancer Center (10) · Astellas Pharma Korea, Inc. (10) · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (9) · National Cancer Institute (NCI) (8)

Often tested with

Tested in the same studies.

Mycophenolic Acid (114) · Fludarabine (74) · Cyclophosphamide (73) · Sirolimus (52) · Methotrexate (42) · Cyclosporine (38) · Fludarabine phosphate (36) · Busulfan (30)

Related medicines

As reviewed, each with the page that says it.

Coming up

From the study records. Dates are the sponsors’ own estimates and often move.

Tested against it · 9 phase 3 studies under way

Tacrolimus is the comparator. A study of two new drugs counts under both.

  • 2Crisaborole · Cairo University · next primary completion Nov 2026
  • 1Obinutuzumab · Hoffmann-La Roche
  • 1Zanubrutinib · BeOne Medicines · next primary completion Oct 2027
  • 1Tegoprubart · Eledon Pharmaceuticals · next primary completion Mar 2029
  • 1Povetacicept · Vertex Pharmaceuticals Incorporated · next primary completion Dec 2028
  • 1Frexalimab · Sanofi · next primary completion Aug 2029
  • 1Inebilizumab · Amgen · next primary completion Sep 2031
Reaching primary completion within a year · 25, 3 in phase 3

Studies that test Tacrolimus, phase 3 first.

Studies

Open first, then newest update. How each study uses Tacrolimus is read from its arms, and is right about nine times in ten. Ask us to read each study. These are the studies that list it as an intervention; a search of ClinicalTrials.gov also finds studies that mention it only in a description, such as earlier treatment.

Testing it · 600

See all 600 studies that test Tacrolimus →

Given beside what is tested · 262 — Tacrolimus is usual care or a partner of the new treatment

Showing 20 of 262.

As the comparator · 77 — what is tested is compared with Tacrolimus

Showing 20 of 77.

What changed recently

From the registry's own updates since Oct 15, 2026.

Codes

What other systems call Tacrolimus · ClinicalTrials.gg INT008530

  • MeSH (NLM) D016559TacrolimusConfirmed ClinicalTrials.gov, NLM, Wikidata
  • UNII (FDA) WM0HAQ4WNMTACROLIMUSConfirmed FDA, NLM, Wikidata
  • RxNorm 484288Confirmed FDA, Wikidata
  • Wikidata Q27130595tacrolimus hydrateConfirmed FDA, NLM, Wikidata
  • NCI Thesaurus C1311TacrolimusConfirmed FDA, Wikidata
  • DrugBank DBSALT000167One source Wikidata

Also registered as tacrolimus anhydrous (UNII Y5L2157C4J · RxNorm 235991).

“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.