Drug Database
FE

fenofibrate (Triglide)

✓ Approved

SkyePharma PLC · PPARA · Small Molecule

What is fenofibrate?

fenofibrate is a small molecule developed by SkyePharma PLC. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand NamesTriglide
CompanySkyePharma PLC
Drug ClassSmall Molecule
Molecular TargetPPARA
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, SkyePharma PLC

Mechanism of Action

Molecular Targets

fenofibrate acts on 1 molecular target:

PPARAperoxisome proliferator activated receptor alpha (NR1C1, PPAR-alpha)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

fenofibrate is developed for 2 unique indications across 1 therapeutic area.

Therapeutic AreaConditionPhase
Metabolism and nutrition disordersHypertriglyceridaemia✓ Approved
Metabolism and nutrition disordersDyslipidaemia✓ Approved

Related Research Articles

PubMedDiabetologia2026-09-17

Indices of obesity, malnutrition and inflammation are strong predictors of mortality in adults with type 2 diabetes: the FIELD study.

Keech Anthony C AC, O'Connell Rachel L RL, Januszewski Andrzej S AS, Li Liping L et al.

Metabolic risk in type 2 diabetes is not fully captured by standard clinical measures. Use of NMR-based metabolomic indices may enhance risk prediction, but their role in individuals with type 2 diabetes is unresolved. We analysed data from 9550 adults with type 2 diabetes who were followed for 5 years in the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study. The composite index MVX (metabolic vulnerability), and its components IVX (inflammation vulnerability index) and MMX (metabolic malnutrition index), were derived from baseline plasma NMR. Associations with mortality and non-fatal events were assessed using Cox models adjusted for clinical variables and treatment allocation. Predictive performance was assessed using C statistics and variable contribution analysis. All three indices were associated with total mortality. Participants in the highest MVX quintile (Q5) had an over fourfold greater unadjusted mortality risk, and more than double the risk after adjustment (HR 2.31; 95% CI 1.71, 3.12). Each standard deviation increase in MVX showed a 75% higher mortality risk (95% CI 62, 89; p<0.001). MVX was associated with cardiovascular and cancer mortality separately, and independently predicted non-fatal cardiovascular events and new incident cancer. MMX and IVX showed weaker and less consistent associations. MVX improved risk model discrimination (C statistic 0.725 to 0.737; p=0.0003) and outperformed prior CVD history as a predictor. MVX independently predicts total and cardiovascular mortality in type 2 diabetes, offering prognostic value beyond traditional risk factors. The absolute event rates reflect the treatment standards of the FIELD recruitment period (1997-2000), prior to widespread use of several contemporary cardioprotective therapies. The results support further investigation of the clinical utility of MVX for determination of personalised risk.

PMID 42752966
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PubMedNephron2026-09-15

Sequential liraglutide and setmelanotide therapy in Bardet-Biedl Syndrome: metabolic and renal outcomes in a real-world case report and literature review.

Pasquariello Tommaso T, Secondulfo Floriana F, Roscini Anna Rita AR, Nardi Elisabetta E et al.

Bardet-Biedl syndrome (BBS) is a syndromic ciliopathy characterized by multiple clinical features, including obesity and kidney disease. Therapeutic options remain limited. Setmelanotide, a melanocortin-4 receptor (MC4R) agonist, is approved for obesity in BBS, but real-world data in adults is scarce. This case highlights the synergistic metabolic and nephroprotective effects of a sequential therapeutic strategy combining a glucagon-like peptide-1 (GLP-1) receptor agonist and a MC4R agonist. We report the case of a 37-year-old male with genetically confirmed BBS due to compound heterozygous likely pathogenic BBS10 variants presenting with obesity, insulin resistance, dyslipidemia, albuminuria and metabolic dysfunction-associated steatotic liver disease (MASLD). Treatment with liraglutide induced modest weight loss (-3.4%, BMI 35.2→34 kg/m²), improved urinary albumin-to-creatinine ratio (uACR) and liver enzymes levels within 8 months. Following discontinuation of liraglutide, setmelanotide therapy was subsequently initiated. After 12 months of treatment, the patient achieved a 10.5% weight loss compared with baseline (BMI 35.2→31.5 kg/m²), normalization of liver transaminases, reduced liver stiffness, and sustained improvement in uACR, while eGFR remained stable. Fasting insulin and HOMA-IR improved. Metformin, statin, and fenofibrate were discontinued, though fenofibrate was later reintroduced for hypertriglyceridemia. Two interventional studies (n≃10-40, 3-52 weeks) similarly reported consistent reduction in metabolic syndrome burden (METs-Z-BMI-score), liver steatosis, stiffness, and enzymes, while renal biomarkers showed stabilization or improvement, supporting potential hepatoprotective and reno-protective effects. Setmelanotide promoted clinically meaningful weight loss and improved liver, kidney, and metabolic parameters in an adult patient carrying BBS10-likely pathogenic variants. Together with emerging evidence for interventional studies, these findings suggest that MC4R agonism may confer organ-level and cardiometabolic benefits beyond weight reduction.

PMID 42743093
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PubMedCongenital anomalies2026-09-11

Pregnancy Outcomes Following Maternal Fenofibrate Exposure.

Uysal Nusret N, Colak Onur O, Gultekin Onur O, Akici Ahmet A

Fenofibrate is a fibric acid derivative used in the management of severe hypertriglyceridemia, a condition that may lead to serious maternal and fetal complications during pregnancy. However, evidence regarding the safety of fenofibrate exposure in pregnancy remains extremely limited, and the available human data are largely restricted to isolated case reports. The aim of this study was to evaluate pregnancy outcomes of women who consulted a university teratology information service (TIS) due to fenofibrate exposure during pregnancy. The data for this retrospective case series include consultation records and follow-up interviews of pregnant women who consulted the TIS at Marmara University Hospital due to fenofibrate exposure between 2012 and 2025. Eleven pregnancies with fenofibrate exposure were identified, and pregnancy outcomes were available for 10 pregnancies. Six pregnancies resulted in live births and four resulted in stillbirth. Due to one twin pregnancy, a total of 11 infants were recorded, including seven live-born and four stillborn infants. No major congenital malformations were identified among live-born infants. One child was reported to have been diagnosed with autism during follow-up. Although the proportion of stillbirths in this series appears higher than expected, most affected pregnancies were complicated by significant maternal comorbidities, including severe hypertriglyceridemia, diabetes mellitus, hypertension, and acute pancreatitis, which are known risk factors for adverse pregnancy outcomes. Therefore, the observed stillbirths may be related to underlying maternal disease rather than fenofibrate exposure. Overall, the findings of this case series do not suggest a clear teratogenic signal associated with maternal fenofibrate exposure during pregnancy.

PMID 42723444
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PubMedNanomaterials (Basel, Switzerland)2026-09-11

Preparation and Characterization of Fenofibric Acid-Loaded Electrospun Fibrous Mats.

Bitay Enikő E, Tóth Gergő G, Szabó Zoltán-István ZI

Fenofibric acid-loaded microfibrous mats were produced by electrospinning using polyvinylpyrrolidone (PVP) as a carrier polymer. Fenofibric acid, obtained through alkaline hydrolysis of fenofibrate, was incorporated into PVP solutions and processed under optimized electrospinning conditions to obtain uniform, defect-free fibers. The morphology and average fiber diameter were examined by scanning electron microscopy, revealing homogeneous, continuous fibers. Thermal analysis revealed the disappearance of the characteristic melting endotherm of fenofibric acid following electrospinning, indicating a substantial alteration in its thermal behavior within the polymer matrix. In vitro dissolution tests in artificial saliva showed a markedly enhanced release rate of fenofibric acid from the fibrous mats compared with the pure crystalline form, indicating a significant improvement in apparent solubility. These findings highlight the potential of PVP-based electrospun fiber formulation as an efficient carrier for the active metabolite of fenofibrate.

PMID 42726586
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PubMedOphthalmology2026-09-10

Association of Common Anti-Inflammatory Medications with Reduced Risk of Vision-Threatening Diabetic Retinopathy in Type 2 Diabetes.

Bison Henry S HS, Zhu Angela S AS, Borissov Martin M, Jung Hee-Jae HJ et al.

To determine whether adults with type 2 diabetes mellitus (T2DM) using cetirizine, ibuprofen, or prednisone have a reduced incidence of diabetic macular edema (DME) and proliferative diabetic retinopathy (PDR). Retrospective propensity score-matched cohort study. Adults with T2DM and documented eye-care in the TriNetX US Collaborative Network who had two documented uses of cetirizine, ibuprofen, prednisone, fenofibrate, or gabapentin between January 1, 2005, and March 1, 2025. Each drug cohort was 1:1 propensity score-matched on 44 covariates against non-users; fenofibrate served as a positive control, and gabapentin served as both a negative control and an active comparator. Residual confounding was assessed using eight ophthalmic negative-control outcomes (NCOs) and E-values. Nine sensitivity analyses tested comparison to users of gabapentin, alternative outcome windows, a new-user design, glycemic strata, matching for drug indication, and exposure duration. Incident DME and PDR within 3 years of the index date. Matched-pair counts ranged from 18,762 to 86,846. Cetirizine was associated with reduced DME (hazard ratio [HR], 0.62; 95% confidence interval [CI], 0.51-0.74) and PDR (HR, 0.59; 95% CI, 0.46-0.77); ibuprofen with reduced DME (HR, 0.63; 95% CI, 0.56-0.69) and PDR (HR, 0.48; 95% CI, 0.41-0.56); and prednisone with reduced DME (HR, 0.46; 95% CI, 0.41-0.52) and PDR (HR, 0.36; 95% CI, 0.30-0.43). Fenofibrate showed associations of similar magnitude (DME HR, 0.57; 95% CI, 0.48-0.68; PDR HR, 0.59; 95% CI, 0.45-0.77); gabapentin showed no association (DME HR, 0.95; 95% CI, 0.88-1.02; PDR HR, 1.04; 95% CI, 0.93-1.15). Point E-values for the investigational drugs ranged from 2.57 to 4.97 (lower 95% CI bound, 1.93 to 4.06). The NCO panel was near null for cetirizine and ibuprofen and showed mild protective bias for prednisone and fenofibrate. Findings persisted across the nine sensitivity analyses. Cetirizine, ibuprofen, and prednisone were associated with reduced incidence of DME and PDR in adults with T2DM, with effect sizes comparable to those of the fenofibrate positive control. These findings support prospective evaluation of anti-inflammatory medications for the prevention of vision-threatening diabetic retinopathy.

PMID 42722111
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PubMedThe AAPS journal2026-09-10

Dissolution Enhancement by Binding Agents: A Potential Shortcut to Improving Bioavailability?

Chronowska Maja M, Dressman Jennifer J

The poor water solubility of many drugs and drug candidates is a limiting factor to their bioavailability after oral administration. Although dissolution enhancing approaches, e.g. amorphous solid dispersions, are often used to make enabling formulations, these are usually associated with high development and manufacturing costs. This study focuses on the potential of using pharmaceutical excipients (binders) in simple tablet formulations to improve drug release and thus bioavailability. Loperamide hydrochloride, fenofibrate, compound c0 (a drug candidate) and carvedilol were chosen for this study as poorly water-soluble model compounds. Their solubility in the absence and presence of three polymeric binders, polyvinylpyrrolidone (PVP) K90, hydroxypropyl methylcellulose (HPMC) E4M and E15, and methylcellulose (MC) was tested in FaSSIF-V1 buffer and biorelevant media. Additionally, after wet granulation using PVP K90 or HPMC E15 as binders and tablet compression, the dissolution of the model compounds was tested in FaSSIF-V1 buffer and biorelevant media. Although solubilities and dissolution profiles of the model compounds were mostly improved by the binders, correlation between solubility in buffers and dissolution from the tablets in biorelevant FaSSIF-V1 was poor, indicating that dissolution experiments may be a better screening tool than solubility experiments. An important conclusion of these studies is that it is possible to increase the rate, and in some cases, the extent of dissolution of four poorly soluble drugs using wet granulation with polymeric binders, followed by tablet compression - a simple and cost-effective approach to improving drug performance.

PMID 42717179
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