R-GENE 10 (arginine hydrochloride)
R-GENE 10 is indicated for the treatment of Panhypopituitarism; Pituitary Dwarfism; Chromophobe Adenoma; Craniopharyngioma; Acromegaly; Gigantism.
Details
- Status
- Prescription
- First Approved
- 1973-02-28
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
R-GENE 10 Approval History
What R-GENE 10 Treats
6 indicationsR-GENE 10 is approved for 6 conditions since its original approval in 1973. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Panhypopituitarism
- Pituitary Dwarfism
- Chromophobe Adenoma
- Craniopharyngioma
- Acromegaly
- Gigantism
R-GENE 10 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.
Drugs Similar to R-GENE 10
3 of 10FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05855330 ART-COVID19 | STUDY00005572 2025P010543 | Ph 2 | recruiting | Arginine Replacement Therapy in COVID-19 |
| NCT07167693 | 24-12-7395 | Ph 1, Ph 2 | recruiting | Phase 1 Trial of Arginine Hydrochloride for the Management of Diabetic Ketoacidosis in Type 2 Diabetes |
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.
R-GENE 10 FDA Label Details
Indications & Usage
FDA Label (PDF)R-GENE 10 is indicated for the treatment of Panhypopituitarism; Pituitary Dwarfism; Chromophobe Adenoma; Craniopharyngioma; Acromegaly; Gigantism.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.