DOJOLVI (triheptanoin)
DOJOLVI is indicated for the treatment of Long-Chain Fatty Acid Oxidation Disorders.
How DOJOLVI Works
Triheptanoin is a medium-chain triglyceride consisting of three odd-chain, 7-carbon length fatty acids known as heptanoate. These fatty acids provide a source of calories and lipids that bypass the specific enzyme deficiencies associated with long-chain fatty acid oxidation disorders. By circumventing these metabolic blocks, the drug enables the body to produce energy and replace necessary fatty acids.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2020-06-30
- Patent Cliff
- 2034
- Routes
- ORAL
- Dosage Forms
- LIQUID
DOJOLVI Approval History
What DOJOLVI Treats
1 indicationsDOJOLVI is approved for 1 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Long-Chain Fatty Acid Oxidation Disorders
DOJOLVI Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Clinical Trial Registry
17 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06067802 | STUDY23040121 UX007-IST237 | Ph 2 | suspended | Study of Triheptanoin for the Prevention of Hypoglycemia in Patients With Medium Chain Acyl-CoA Dehydrogenase Deficiency (MCADD) |
| NCT05933200 | UX007-CL302 2022-001539-10, 2023-509809-76-00 | Ph 3 | active not recruiting | A Study to Determine the Effect of Triheptanoin Compared With Even-Chain MCT on MCEs in Pediatric Patients With LC-FAOD |
| NCT07097311 | STUDY25050173 | Ph 2 | recruiting | Study to Evaluate the Use of Triheptanoin in Patients With Medium Chain Acyl-CoA Dehydrogenase Deficiency (MCADD) |
| NCT06340685 | STUDY23050042 UX007-IST236 | Ph 1 | recruiting | Triheptanoin for Children With Primary-Specific Pyruvate Dehydrogenase Complex (PDC) Deficiency |
| NCT02408354 HEMIHEP | C14-53 | Ph 2 | completed | Pilot Study, Comparative, Single-center, Randomized, Crossover, Double-blind, Against Placebo, Testing the Effectiveness of Triheptanoin Oil in Alternating Hemiplegia of Childhood |
| NCT02919631 | C15-54 | Ph 2 | completed | Triheptanoin in Mc Ardle |
| NCT03181399 results posted | 122016-013 1R01NS094257-01A1 | Ph 2 | completed | Diet Treatment Glucose Transporter Type 1 Deficiency (G1D) |
| NCT03642860 | #20171012 Trihep 2017-004153-17 | Ph 2 | completed | The Effect of Triheptanoin on Fatty Acid Oxidation and Exercise Tolerance in Patients With Glycogenoses |
| NCT03301532 results posted | STU 102015-091 R01NS094257-01A1 | Ph 2 | completed | Compatibility of C7 With Ketogenic Diet in Patients Diagnosed With G1D |
| NCT03041363 | STU 062016-105 R01NS094257 | Ph 1 | completed | Treatment Development of Triheptanoin (G1D) |
| NCT02036853 GLUT1DS results posted | 2013-NEUR-001 | Ph 2 | completed | An Open-Label Trial of Triheptanoin in Patients With Glucose Transporter Type-1 Deficiency Syndrome |
| NCT03506425 results posted | Pro00092250 | Ph 1, Ph 2 | completed | A Pilot Trial of Triheptanoin for People With Amyotrophic Lateral Sclerosis (PALS) |
| NCT02018315 results posted | UTSW 122010-186 | Ph 1 | completed | Treatment Development for Glucose Transporter Type I Deficiency Syndrome (G1D) |
| NCT02432768 | H-8-2014-006 2014-003644-12 | Ph 2 | completed | The Effect of Triheptanoin in Adults With McArdle Disease (Glycogen Storage Disease Type V) |
| NCT02021526 | PASCG1D2014 | Ph 1, Ph 2 | withdrawn | Triheptanoin (C7 Oil), a Food Supplement, for Glucose Transporter Type I Deficiency (G1D) |
| NCT00947960 | 009-103 | Ph 2 | completed | Triheptanoin Treatment Trial for Patients With Adult Polyglucosan Body Disease |
| NCT01379625 Triheptanoin results posted | FD003895 | Ph 2 | completed | Study of Triheptanoin for Treatment of Long-Chain Fatty Acid Oxidation Disorder |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DOJOLVI FDA Label Details
Indications & Usage
FDA Label (PDF)DOJOLVI is indicated for the treatment of Long-Chain Fatty Acid Oxidation Disorders.
DOJOLVI Patents & Exclusivity
Patents (2 active)
Exclusivity
Pro Intelligence Preview
Deep insights for DOJOLVI
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2034
- • 2 active patents
Trial Analysis
- • 17 total trials
- • Stage: Declining
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment