R-Gene 10

(Arginine)

Phase 2Small molecule

R-Gene 10 is one of 107 small molecule programs targeting Metastatic Malignant Neoplasm in the Brain. It is currently in Phase 2.

Indications

Total Trials

Active Trials

106

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Metastatic Malignant Neoplasm in the BrainRecruiting

EncephalopathyActive, not recruiting

Sickle Cell DiseaseCompleted

Quality of LifeUnknown status

MRITerminated

ThalassemiaActive, not recruiting

Metastatic Malignant Neoplasm in the BrainPhase 1

Recruiting

EncephalopathyPreclinical

Active, not recruiting

Sickle Cell DiseasePhase 2

Completed

Quality of LifePreclinical

Unknown status

MRIPreclinical

Terminated

ThalassemiaPreclinical

Active, not recruiting

Competition

Competitive Landscape

91 competitors in Sickle Cell Disease

#DrugCompanyPhaseTrials

Campath

GGenzyme, a Sanofi Company

Phase 3

14 2

Ritalin

Novartis

Phase 3

2 3

Toradol

JJavelin Pharmaceuticals

Phase 3

2 4

Fludara

Sanofi

Phase 2

10 5

Cellcept

Roche

Phase 2

6 6

Aqvesme

AAgios Pharmaceuticals, Inc.

Phase 3

4 7

PIASKY

Roche

Phase 3

2 8

Tepadina

Jazz Pharmaceuticals

Phase 2

4 9

Rapamune

PPrism Pharmaceuticals

Orencia

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

N/ARecruiting

Encephalopathy

NCT06483737

Q1 2028

PreclinicalRecruiting

Sickle Cell Disease

NCT02447874

Q4 2028

Phase 1Recruiting

Metastatic Malignant Neoplasm in the Brain

NCT06328686

Q1 2029

Phase 1Not yet recruiting

Platinum-Resistant Ovarian Cancer

NCT07772882

Clinical

Trials by Indication[1]

Sickle Cell Disease2 trials

Arginine Therapy in Sickle Cell Disease-VOC Clinical Trial

Completed·UUCSF Benioff Children's Hospital Oakland·Phase 2·NCT01796678·56 enrolled

Arginine Therapy for the Treatment of Vaso-Occlusive Events in Children With Severe Sickle Cell Disease

Recruiting·EEmory University·Preclinical·NCT02447874·21 enrolled

Encephalopathy1 trial

Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE)

Recruiting·GGeneral Hospital of Shenyang Military Region·N/A·NCT06483737·174 enrolled

Malaria1 trial

Arginine Malaria Trial: Study of Adjunctive Arginine in Falciparum Malaria

Completed·MMenzies School of Health Research·Phase 1/2·NCT00147368·50 enrolled

MRI1 trial

The Aim is to Estimate the Total Amount of Insulin-producing Cells in the Pancreas by MRI.

Terminated· Pfizer logo

Pfizer·N/A·NCT00280085·29 enrolled

Diabetes1 trial

Ghrelin and Beta Cell Function in Diabetes

Withdrawn·JJenny Tong, MD, MPH·Phase 1·NCT02440061

8 more indications

Anemia1 trial

Effectiveness of Arginine as a Treatment for Sickle Cell Anemia

Completed·UUCSF Benioff Children's Hospital Oakland·Phase 2·NCT00513617·128 enrolled

Thalassemia1 trial

Thalassemia (Cooley's Anemia) Clinical Research Network (TCRN)

Completed·CCarelon Research··NCT00000623·1,000 enrolled

Argininosuccinic Aciduria1 trial

Arginine and Buphenyl in Patients With Argininosuccinic Aciduria (ASA), a Urea Cycle Disorder

Completed·BBrendan Lee·Phase 2·NCT00345605·12 enrolled

Quality of Life1 trial

Improving Quality of Life and Daily Life Activities With Bioarginine in Patients With COPD

Unknown status·UUniversity of Milan·N/A·NCT05412160·152 enrolled

Hepatitis1 trial

Treatment of Alcohol-Related Hepatitis With Arginine

Withdrawn·NNational Center for Complementary and Integrative Health (NCCIH)·Phase 2·NCT00200746

Platinum-resistant Ovarian Cancer1 trial

Phase I Study of Supplemental Arginine With Chemotherapy and Immunotherapy in Platinum Resistant Ovarian, Fallopian Tube, and Peritoneal Cancer

Not yet recruiting·RRebecca Arend·Phase 1·NCT07772882·24 enrolled

Metastatic Malignant Neoplasm in the Brain1 trial

Arginine With Whole Brain Radiation Therapy for the Treatment of Brain Metastases

Recruiting·EEmory University·Phase 1·NCT06328686·10 enrolled

Unspecified1 trial

N-Acetylcysteine and Arginine Administration in Diabetic Patients

Terminated·UUniversity of Turin, Italy·Phase 4·NCT00569465·24 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

R-GENE 10

NDA NDA016931

Sources

References

[1]
ClinicalTrials.gov — 14 trial records for Arginine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Arginine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Arginine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA016931). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Pharmacia and Upjohn company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: PPharmacia and Upjohn

R-Gene 10

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q1 2028

Q4 2028

Q1 2029

Trials by Indication[1]

Sickle Cell Disease2 trials

Encephalopathy1 trial

Malaria1 trial

MRI1 trial

Diabetes1 trial

Anemia1 trial

Thalassemia1 trial

Argininosuccinic Aciduria1 trial

Quality of Life1 trial

Hepatitis1 trial

Platinum-resistant Ovarian Cancer1 trial

Metastatic Malignant Neoplasm in the Brain1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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