Drug name
Last update: Aug 2026Efruxifermin (mAb)
Developer(s)
Drug information
Efruxifermin (EFX)
investigational
Biotherapeutic
Not provided
EFX has been engineered to mimic the biological activity of fibroblast growth factor 21 (FGF21), which regulates multiple metabolic pathways and cellular processes. By delivering sustained and balanced signalling through FGF21’s receptors in liver and adipose tissue, EFX has the potential to treat MASH by addressing all core drivers of disease progression. EFX leverages the whole body to improve metabolic balance. The first Phase 2b study evaluated the efficacy and safety of EFX in patients with pre-cirrhotic MASH, fibrosis stage 2 or 3 (F2-F3). The study met its primary endpoint of ≥1 stage improvement in fibrosis with no worsening of MASH after 24 weeks of treatment for both the 50 mg EFX (41%) and 28 mg EFX (39%) dose groups, compared to 20% for the placebo arm.
Unknown
Unknown
Therapeutic area(s)
- Other(s) : "MASH"
- Treatment
Administration route
Subcutaneous
Associated long-acting platforms
Monoclonal antibodies and antibody drug conjugates
Use of drug
- Administered by a nurse
- Administered by a specialty health worker
- Self-administered
Not provided
Dosage
Not provided
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Associated compounds, formulations and regimens
Not provided
Associated technologies
Not provided
Additional information
Developer(s)
Drug structure
Scale-up and manufacturing prospects
Not provided
Not provided
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Excipients & delivery device(s)
Not provided
Not provided
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Safety, Efficacy and Evidence Summary
Not provided
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Efruxifermin composition
Efruxifermin composition, comprising sugar, 20 to about 200 mM arginine/arginine-HCI or arginine/glutamic acid, and a surfactant
WO2023064808
Formulation
AKERO THERAPEUTICS, INC.
Not provided
October 12, 2042
Pending: AE, AP, AU, BR, CA, CL, CN, CO, CR, EA, EG, EP, HK, ID, IL, IN, JO, JP, KR, MA, MX, MY, NZ, PA, PE, PH, SA, SG, TH, UA, US, VN, ZA
Efruxifermin Method of Treatment of metabolic diseases
Method of treating metabolic disorder (incl. type 1 diabetes, obesity etc.) using Efruxifermin (SEQ ID NO 41)
WO2013033452
Method of Treatment
AMGEN INC
Not provided
August 30, 2032
Granted: AU Pending: JP, MX, US Not in force: EP
Efruxifermin polypetide
Efruxifermin polypetide specifically claimed as SEQ ID NO 47
WO2010129503
Not provided
AMGEN INC.
Not provided
May 4, 2030
Granted: AR, BR, AU, CA, CN, CO, CR, EA (KZ, RU), EP (CH, DE, FR, IT, GB, LI), HK, IN, ID, IL, JP, KR, LB, MY, MX, MA, NZ, PA, GC, PE, PH, SG, ZA, TH, TW, TN, UA, US Pending: BW, EG, JO, LY, VN Not in force: AM, AZ, BY, KG, TJ, TM, MD, AT, BE, BG, CY, CZ, DE, DK, EE, ES, FI, GR, HR, HU, IE, IS, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, SE, SI, SK, TR, BA, AL, RS
Broad FGF21 mutant polypeptides, covering mutants of Efruxifermin IgG constant domain
The invention provides nucleic acid molecules encoding FGF21 mutant polypeptides, FGF21 mutant polypeptides, pharmaceutical compositions comprising FGF21 mutant polypeptides, and methods for treating metabolic disorders using such nucleic acids, polypeptides, or pharmaceutical compositions.
WO2009149171
Compound
AMGEN INC.
Not provided
June 3, 2029
Granted: DZ, AU, BR, CA, CN, CO, EA (KZ, RU), EP (CH, DE, FR, GB, LI), HK, IN, ID, IL, JP, KR, MY, MX, MA, NZ, PE, SG, ZA, TW, TN, UA, US, VN Pending: AR, BW, CL, CR, EG, JO, LY, GC, UY Not in force: AM, AZ, BY, KG, TJ, TM, MD, AT, BE, BG, CY, CZ, DE, DK, EE, ES, FI, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, SE, SI, SK, TR, BA, AL, RS