pharma · Retinitis Pigmentosa · Dyslipidaemia
Laboratoire HRA Pharma
Laboratoire HRA Pharma is a pharma organization headquartered in CHATILLON, FR. Primary therapeutic focus areas include Retinitis Pigmentosa, Dyslipidaemia, Hemophilia, Allergic Conjunctivitis, Leber congenital amaurosis
Phase 3 · small molecule · Dyslipidaemia
Pravafenix 40 mg/160 mg hard capsules is a fixed-dose combination product developed by Laboratoire HRA Pharma for the treatment of mixed dyslipidaemia. The formulation combines rosuvastatin 20 mg with fenofibrate 160 mg in a single capsule. Fenofibrate is an established fibrate approved across multiple jurisdictions (U
Internal code ROFE-III-24-1
Pravafenix 40 mg/160 mg hard capsules is a fixed-dose combination product developed by Laboratoire HRA Pharma for the treatment of mixed dyslipidaemia. The formulation combines rosuvastatin 20 mg with fenofibrate 160 mg in a single capsule. Fenofibrate is an established fibrate approved across multiple jurisdictions (US, EU, Australia) with a long regulatory history dating to 2009 in Europe and earlier approvals in the US. The program is currently in Phase III development, with an active double-blind, randomised, parallel-arm trial comparing Pravafenix against a comparator arm of pravastatin 40 mg plus fenofibrate 160 mg in patients with mixed dyslipidaemia. The trial is designed to evaluate efficacy and safety over a 12-week treatment period. No mechanism of action, target designation, or lead investigator information has been disclosed. The program represents a combination strategy in the dyslipidaemia space, where multiple approved therapies already exist. Regulatory status and approval timelines remain undisclosed.
Mixed dyslipidaemia remains a significant cardiovascular risk factor affecting millions globally, with unmet needs in patient populations requiring dual lipid-lowering therapy. Current treatment paradigms often involve separate dosing of statins and fibrates, creating adherence challenges. A fixed-dose combination addressing this gap could improve medication compliance and clinical outcomes. The competitive landscape for dyslipidaemia is crowded with approved therapies including PCSK9 inhibitors (PRALUENT, REPATHA, LEQVIO), bempedoic acid combinations (NILEMDO), inclisiran (LEQVIO), and other agents targeting LDL-C and triglycerides. Pravafenix enters a mature market where combination products offer differentiation through convenience rather than novel mechanisms. The patient population for mixed dyslipidaemia is substantial, particularly among those inadequately controlled on monotherapy. Commercial significance depends on regulatory approval, reimbursement positioning, and competitive pricing relative to existing fixed-dose combinations and separate therapies. The Phase III trial design comparing against pravastatin plus fenofibrate suggests the sponsor is positioning rosuvastatin as a potentially superior statin component, though clinical differentiation remains to be demonstrated.
Drug Class: Fixed-dose combination lipid-lowering agent
Modality: Small molecule
Components:
Route of Administration: Oral (hard capsule)
Therapeutic Class: Cardiovascular system (C10)
Fenofibrate Regulatory Status: Fenofibrate is approved in the US (multiple ANDA applications from manufacturers including AbbVie, Cipla, Dr. Reddy's, Lupin, Mylan, Sun Pharma, and others), EU (approved under multiple MAH including Viatris Healthcare, Laboratoires SMB, Fournier Laboratories), and Australia (PBS-listed with codes 13469X, 13587D, 9022W, 9023X). First EU approval dates to 31 December 2009 (EMEA/H/C/002559). US approvals span multiple ANDA applications with the earliest referenced NDA dating to 1989 (NDA019304).
Mechanism of Action: Not yet disclosed for the combination product
Target: Not yet disclosed
Patent Status: Not yet disclosed
Also known as: disorder of lipid metabolism, dyslipidaemia, dyslipidemia, lipid metabolism disorder
An inherited metabolic disorder caused by an enzyme deficiency, resulting in an inability to oxidize fatty acids for energy production.
ClinicalTrials.gov lists 14 registered studies for Lipid Metabolism Disorder (AACT aggregate).
Phase breakdown: NA (11), PHASE1 (1), PHASE3 (1), PHASE4 (1)
Common investigational therapies:
Disease data sourced from MONDO Disease Ontology (MONDO:0002525), Orphanet — inherited lipid metabolism disorder, NCT00651963, NCT01071278, NCT02603770, NCT03236116, NCT03392701, AACT (ClinicalTrials.gov aggregate), ClinicalTrials.gov, Open Targets Platform (CC BY 4.0).
Phase III active enrollment
Double-blind, randomised, parallel-arm trial comparing Pravafenix (rosuvastatin 20 mg + fenofibrate 160 mg) versus pravastatin 40 mg + fenofibrate 160 mg over 12 weeks in mixed dyslipidaemia patients.
The dyslipidaemia therapeutic space includes multiple approved agents across distinct mechanisms. PCSK9 inhibitors (PRALUENT by Regeneron, REPATHA by Amgen, LEQVIO by Novartis) dominate the LDL-C lowering segment and are approved globally. Inclisiran (LEQVIO) offers a newer mechanism with less frequent dosing. Bempedoic acid (NILEMDO by Esperion) and its combination formulations target purine metabolism. Icosapent ethyl (VAZKEPA by Seqirus) addresses triglyceride elevation. Mipomersen (KYNAMRO) and lomitapide (LOJUXTA) target rare severe dyslipidaemias. Volanesorsen (WAYLIVRA) addresses familial chylomicronaemia. Bile acid sequestrants (CHOLESTAGEL) remain available. Pravafenix competes as a fixed-dose combination of established agents (statin plus fibrate), positioning convenience and adherence as differentiators rather than novel efficacy. The Phase III comparator arm (pravastatin plus fenofibrate) suggests positioning rosuvastatin as clinically superior to pravastatin within the combination format. Direct head-to-head data against PCSK9 inhibitors or other newer agents is not disclosed. Market positioning will depend on regulatory approval, reimbursement, and clinical trial outcomes demonstrating superiority or non-inferiority versus the comparator arm.
| Therapy | Company | Mechanism | Status |
|---|---|---|---|
| PRALUENT | Regeneron UK Limited | — | approved |
| REDEMPLO | Arrowhead Pharmaceuticals Ireland Limited | — | approved |
| VAZKEPA | Seqirus (Australia) Pty Ltd | — | approved |
| NILEMDO | Esperion Therapeutics | — | approved |
| EVKEEZA | Ultragenyx UK Limited | — | approved |
| KYNAMRO | — | — | approved |
| REPATHA | Amgen | — | approved |
| TREVACLYN | — | — | approved |
| CHOLESTAGEL | — | — | approved |
| LEQVIO | Novartis Pharmaceuticals | — | approved |
| LOJUXTA | — | — | approved |
| WAYLIVRA | — | — | approved |
| VOLANESORSEN SODIUM | — | Apolipoprotein C-III mRNA antisense inhibitor | Approved |
| TORIPALIMAB | — | Programmed cell death protein 1 antagonist | Approved |
| SIMVASTATIN | — | HMG-CoA reductase inhibitor | Approved |
| ROSUVASTATIN CALCIUM | — | HMG-CoA reductase inhibitor | Approved |
| PREDNISONE | — | Glucocorticoid receptor agonist | Approved |
| PREDNISOLONE | — | Glucocorticoid receptor agonist | Approved |
| PRAVASTATIN SODIUM | — | HMG-CoA reductase inhibitor | Approved |
| PITAVASTATIN CALCIUM | — | HMG-CoA reductase inhibitor | Approved |
Additional associated therapies sourced from Open Targets Platform (CC0), linked to NovaPharmaNews drug profiles where matched.
FDA (United States): Pravafenix approval status not yet disclosed. Fenofibrate component is approved via multiple ANDA applications (earliest NDA019304 dating to 1989). Rosuvastatin is approved as a statin component.
EMA (European Union): Pravafenix approval status not yet disclosed. Fenofibrate is approved under EMEA/H/C/002559 (authorised 31 December 2009) and other product numbers, with multiple MAH including Viatris Healthcare Limited, Laboratoires SMB S.A., and Fournier Laboratories Ireland Ltd.
PMDA (Japan): Regulatory status not yet disclosed.
NMPA (China): Fenofibrate is in clinical trials (NCT02823366 referenced), suggesting ongoing development activity in China.
Australia (TGA): Fenofibrate is approved and PBS-listed with codes 13469X, 13587D, 9022W, 9023W, with sponsors including Alphapharm Pty Ltd, Apotex Pty Ltd, Arrotex Pharmaceuticals, Cipla Australia, and Generic Health Pty Ltd.
Pravafenix Combination Product: No approval dates, regulatory designations, or filing status disclosed. Phase III trial is active.
Pravafenix is a fixed-dose combination being developed for the treatment of mixed dyslipidaemia, a condition characterised by elevated cholesterol and triglycerides.
Pravafenix approval status has not been disclosed. The program is currently in Phase III clinical development.
Laboratoire HRA Pharma is the sponsor and developer of Pravafenix. No manufacturing partners or licensees have been disclosed.
Pravafenix 40 mg/160 mg contains rosuvastatin 20 mg and fenofibrate 160 mg in a hard capsule formulation.
The mechanism of action for the Pravafenix combination has not been disclosed. Rosuvastatin is a statin that lowers LDL cholesterol, and fenofibrate is a fibrate that reduces triglycerides and raises HDL cholesterol.
Pravafenix is in Phase III clinical development. An active double-blind, randomised trial is comparing it against pravastatin 40 mg plus fenofibrate 160 mg over 12 weeks.
The Phase III trial is double-blind, randomised, and parallel-arm, comparing Pravafenix against a comparator arm of pravastatin 40 mg plus fenofibrate 160 mg in patients with mixed dyslipidaemia over a 12-week treatment period.
Yes, fenofibrate is approved in the US (via multiple ANDA applications), EU (approved since 31 December 2009), and Australia (PBS-listed). It is an established fibrate therapy.
Competitors include PCSK9 inhibitors (PRALUENT, REPATHA, LEQVIO), bempedoic acid (NILEMDO), icosapent ethyl (VAZKEPA), inclisiran (LEQVIO), mipomersen (KYNAMRO), and other lipid-lowering agents.
The internal code is ROFE-III-24-1.
No licensing partners or collaborators have been disclosed for Pravafenix.
Pravafenix is administered orally as a hard capsule formulation.
The first disclosure date for Pravafenix has not been disclosed.
Pravafenix is being developed for patients with mixed dyslipidaemia, a condition requiring management of both elevated cholesterol and triglycerides.
Patent status for Pravafenix has not been disclosed.
Projected peak sales figures have not been disclosed.
Pravafenix 40 mg/160 mg hard capsules → Drug → Target → Indication → Company → Trials → Competitors
Strategic Positioning: Laboratoire HRA Pharma's development of Pravafenix represents a combination strategy in a mature dyslipidaemia market. The fixed-dose format targets medication adherence and convenience rather than novel mechanisms, a pragmatic approach in a space dominated by PCSK9 inhibitors and other advanced therapies. The choice of rosuvastatin over pravastatin as the statin component in the Phase III comparator arm suggests the sponsor believes rosuvastatin offers clinical advantages, though this must be demonstrated in trial results.
Competitive Implications: Pravafenix faces significant competition from established monotherapies and fixed-dose combinations already in the market. PCSK9 inhibitors have captured significant market share in LDL-C lowering. The program's success depends on: (1) demonstrating non-inferiority or superiority versus the pravastatin comparator arm, (2) regulatory approval across key markets, (3) reimbursement positioning, and (4) differentiation in a crowded space. The lack of disclosed mechanism of action or target designation limits ability to assess novel aspects.
Future Catalysts: Phase III trial completion and results announcement will be the primary near-term catalyst. Regulatory submissions and approval decisions in the US, EU, and other markets will follow. Commercial launch timing and market uptake will depend on competitive pricing, reimbursement decisions, and clinical practice adoption. No expected milestone dates or labels have been disclosed.
Development Gaps: Mechanism of action, target, lead investigator, first disclosure date, and expected next milestone information remain undisclosed, limiting full strategic assessment.
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Intelligence compiled from public regulatory and clinical sources (FDA, EMA, ClinicalTrials.gov and company disclosures). Figures may be editorial or analyst estimates; verify against primary sources before relying on them.