Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
L-arginine · 1 trial · 2 indications
The total amount of parenteral opioids used by participants measured in mg/kg of IV morphine equivalents. The total is calculated after study drug delivery for participants in the emergency department (ED) and during hospital stay.
| Arm | Type | Description |
|---|---|---|
| L-Arginine | EXPERIMENTAL | Participants will be randomized to receive an intravenous (IV) infusion of L-arginine (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital. |
| Loading Dose and L-Arginine | EXPERIMENTAL | Participants will be randomized to receive an intravenous (IV) infusion of one-time loading dose of L-arginine (200 mg/kg) followed by standard dose (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital. |
| Placebo | PLACEBO_COMPARATOR | Participants will be randomized to receive an intravenous (IV) infusion of placebo (normal saline 1-2 ml/kg) three times a day until time of discharge from the emergency department (ED) or hospital. |
| Name | Type | Description |
|---|---|---|
| L-arginine | DRUG | L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital. |
| L-arginine Loading Dose | DRUG | One loading dose of L-arginine will be dispensed intravenously (IV) at 200 mg/kg |
| Placebo | OTHER | Placebo of intravenous (IV) normal saline 1-2 ml/kg three times a day until discharge from the emergency department (ED) or hospital. |
Inclusion Criteria: * Established diagnosis of sickle cell disease (SCD); all genotypes * Pain requiring medical care in an acute care setting (such as the emergency department or ED, hospital ward, day hospital, clinic) not attributable to non-sickle cell causes, that is moderate-to-severe requiri...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 5 | PHASE3 | Etavopivat Low dose |
| Novartis AG Sponsored ADR | NVS | 4 | PHASE3 | Crizanlizumab |
| Sanofi SA Sponsored ADR | SNY | 2 | PHASE3 | PCV21, 20vPCV |
| Vertex Pharmaceuticals Incorporated | VRTX | 3 | PHASE3 | CTX001 |
| Agios Pharmaceuticals, Inc. | AGIO | 2 | PHASE2 | Mitapivat |
| Pfizer Inc. | PFE | 1 | PHASE2 | Osivelotor |
| Bristol-Myers Squibb Company | BMY | 1 | PHASE1 | BMS-986470, Famotidine, Pantoprazole |
| Fulcrum Therapeutics, Inc. | FULC | 1 | PHASE2 | Pociredir |
| Beam Therapeutics, Inc. | BEAM | 2 | PHASE1 | BEAM-101 |
| Editas Medicine, Inc. | EDIT | 2 | PHASE1 | EDIT-301 |
| Disc Medicine, Inc. | IRON | 1 | PHASE1 | DISC-3405 |
| Illumina, Inc. | ILMN | 1 | - | Undisclosed |
L-arginine is an investigational small molecule being studied for the treatment of sickle cell disease, specifically for vaso-occlusive pain episodes. It is currently in Phase 2 clinical development and is not yet approved by the FDA. The drug is being developed by National Healthcare Corp. (NHC).
L-arginine is an amino acid that serves as a precursor for nitric oxide production. In sickle cell disease, it is thought to improve blood flow and reduce vaso-occlusion by enhancing nitric oxide bioavailability, which helps relax blood vessels and decrease red blood cell sickling. This mechanism is being evaluated in clinical trials.
L-arginine is being developed by National Healthcare Corp. (ticker: NHC). The company is conducting clinical trials to evaluate the drug for the treatment of sickle cell disease, specifically for vaso-occlusive pain episodes. The drug is currently in Phase 2 development.
L-arginine is in Phase 2 clinical development for sickle cell disease. It is an investigational drug and has not been approved by the FDA. One Phase 2 trial has been completed, and the drug is not currently in active clinical trials.
L-arginine has one completed Phase 2 clinical trial, NCT02536170, titled "Arginine Therapy for Sickle Cell Disease Pain." This randomized, double-blind, placebo-controlled trial enrolled 108 participants with sickle cell disease and vaso-occlusive pain episodes in the United States. The trial included patients as young as 3 years old.
L-arginine is a form of the amino acid arginine. In the context of sickle cell disease research, L-arginine is the specific formulation being studied. It is also known simply as arginine, and the clinical trial NCT02536170 refers to it as arginine therapy.