R-Gene 10

(Arginine)

Phase 2Small molecule

PPharmacia and Upjohn

R-Gene 10 is one of 195 small molecule programs targeting Hepatitis. It is currently in Phase 2.

Indications

Total Trials

Active Trials

194

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

HepatitisActive, not recruiting

MalariaActive, not recruiting

AnemiaActive, not recruiting

EncephalopathyActive, not recruiting

Sickle Cell DiseaseActive, not recruiting

ThalassemiaActive, not recruiting

HepatitisPhase 2

Active, not recruiting

MalariaPhase 1/Phase 2

Active, not recruiting

AnemiaPhase 2

Active, not recruiting

EncephalopathyPreclinical

Active, not recruiting

Sickle Cell DiseasePhase 2

Active, not recruiting

ThalassemiaPreclinical

Active, not recruiting

Competition

Competitive Landscape

479 competitors in Malaria

#DrugCompanyPhaseTrials

R-Gene 10

PPharmacia and Upjohn

Phase 2

1 2

Biltricide

Bayer

Preclinical

1 3

Stelara

Johnson & Johnson

Preclinical

—4

Hydroxychloroquine Sulfate

Novartis

Preclinical

—5

Iron

WWatson Pharmaceuticals

Preclinical

1 6

IV LBH589

Novartis

Preclinical

1 7

IV Ceftriaxone

RRESnTEC, Institute of Research

Preclinical

1 8

Mefloquine Plus Artesunate

Medicines for Malaria Venture

Preclinical

1 9

RTS,S/AS01E

GSK

Preclinical

4 10

Malarone

Medicines for Malaria Venture

Preclinical

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

Timeline

Expected Milestones

Q2 2027

N/ARecruiting

Encephalopathy

NCT06483737

Clinical

Trials by Indication[1]

Sickle Cell Disease2 trials

Arginine Therapy for the Treatment of Pain in Children With Sickle Cell Disease

Recruiting·EEmory University·Phase 1/2·NCT02447874·21 enrolled

Arginine Therapy in Sickle Cell Disease-VOC Clinical Trial

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

Diabetes1 trial

Ghrelin and Beta Cell Function in Diabetes

Withdrawn·JJenny Tong, MD, MPH·Phase 1·NCT02440061

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

Anemia1 trial

Effectiveness of Arginine as a Treatment for Sickle Cell Anemia

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

Hepatitis1 trial

Treatment of Alcohol-Related Hepatitis With Arginine

Withdrawn·NNational Center for Complementary and Integrative Health (NCCIH)·Phase 2·NCT00200746

6 more indications

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

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

Malaria1 trial

Arginine Malaria Trial: Study of Adjunctive Arginine in Falciparum Malaria

Completed·MMenzies School of Health Research·Phase 1/2·NCT00147368·50 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 — 12 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

Trials by Indication[1]

Sickle Cell Disease2 trials

Diabetes1 trial

Encephalopathy1 trial

Anemia1 trial

Hepatitis1 trial

Thalassemia1 trial

Argininosuccinic Aciduria1 trial

Quality of Life1 trial

MRI1 trial

Malaria1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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