Wednesday, July 8, 2026

Drug profile · INN

tacrolimus

tacrolimus (ADVAGRAF XL) is a fk506-binding protein 1a inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: topical. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved NMPA: clinical trials Dermatologicals (D11) D11AH01
US status approved
Patents linked 4
Pipeline programs 46
News articles 0
Drug details — tacrolimus
US status
approved
Class
Dermatologicals (D11)
Route
TOPICAL
Patents
4
Programs
46
Data quality
0.89

Quick answer

tacrolimus (ADVAGRAF XL) is a fk506-binding protein 1a inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: topical. Current US regulatory status: approved.

Key facts

INN tacrolimus
Brand ADVAGRAF XL
Mechanism FK506-binding protein 1A inhibitor
Target Peptidyl-prolyl cis-trans isomerase FKBP1A
Therapeutic class Dermatologicals (D11)
Route TOPICAL
Formulation TABLET, EXTENDED RELEASE
ATC code D11AH01

Mechanism of action

FK506-binding protein 1A inhibitor

Primary target: Peptidyl-prolyl cis-trans isomerase FKBP1A

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
NMPA clinical trials

Pipeline programs

  1. EFC17559 Phase 3 · Sanofi-Aventis U.S · Dermatitis atopic
  2. EFC17560 Phase 3 · Sanofi-Aventis U.S · Dermatitis atopic
  3. EFC17561 Phase 3 · Sanofi-Aventis U.S · Dermatitis atopic
  4. EFC17599 - AQUA Phase 3 · Sanofi-Aventis U.S · Dermatitis atopic
  5. EFC17600 Phase 3 · Sanofi-Aventis U.S · atopic dermatitis
  6. EFC18554 Phase 3 · Sanofi-Aventis U.S · Kidney transplant rejection
  7. MC-MTX.18/AD Phase 3 · Medac Gesellschaft fuer · moderate to severe atopic dermatitis
  8. P140938J Phase 3 · PARItec · Antisynthetase syndrome-related interstitial lung disease

Related & competitor drugs

  1. beremagene geperpavec Dermatologicals (D03)
  2. dupilumab Dermatologicals (D11)
  3. everolimus Antineoplastic and immunomodulating agents (L01)
  4. imiquimod Dermatologicals (D06)
  5. lebrikizumab Dermatologicals (D11)
  6. retapamulin Dermatologicals (D06)
  1. US 20260108463

    NANOEMULSION FORMULATION WITH IMPROVED TACROLIMUS STABILITY AND SKIN PENETRATION

    Expires Wed Apr 18 2046 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 11291657

    Methods of treating inflammatory bowel disease with AMD3100 and Tacrolimus

    Expires Mon Mar 31 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 10420751

    Methods of treating inflammatory bowel disease with AMD3100 and tacrolimus

    Expires Mon Sep 19 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 6187745

    Method of preventing nephrotoxicity caused by cyclosporins and tacrolimus

    Expires Mon Feb 08 2021 00:00:00 GMT+0000 (Coordinated Universal Time)

    expired

Frequently asked questions

What is tacrolimus?

tacrolimus (ADVAGRAF XL) is a fk506-binding protein 1a inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: topical. Current US regulatory status: approved.

What is the brand name for tacrolimus?

ADVAGRAF XL is a marketed brand name for tacrolimus. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of tacrolimus?

tacrolimus has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.