RO-0622

Summary

Ro-0622 (CHEMBL519846) is a phase-3 clinical-stage small molecule; indicated across 1 condition including severe acute respiratory syndrome.

At a glance

• Status: Max clinical phase 3 (not approved)
• Modality: Small molecule
• Indications: 1 condition
• Clinical trials: 15
• Chemistry: 286.22 Da · C9H11FN6O4

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL519846
Name	RO-0622
Type	Small molecule
Max phase	3
FDA approved	no
PubChem CID	24769759
Molecular formula	C9H11FN6O4
Molecular weight	286.22
InChIKey	KTOLOIKYVCHRJW-XZMZPDFPSA-N

SMILES: C1=CN(C(=O)N=C1N)[C@H]2[C@H]([C@@H]([C@](O2)(CO)N=[N+]=[N-])O)F

IUPAC name: 4-amino-1-[(2R,3S,4R,5R)-5-azido-3-fluoro-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]pyrimidin-2-one

Also known as: Azvudine, RO 0622, Ro-0622, RO-0622, AZVUDINE

Parent form; salt/anhydrous children: CHEMBL1822611

Patent coverage: 236 distinct patent families (645 SureChEMBL compound mentions), from 1 matched compound structure(s). Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).

Gene	Target	Action	pAffinity	Cancer dependency	UniProt
	CoV RNA-dependent RNA polymerase	Inhibition

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

1 indication (0 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
severe acute respiratory syndrome	3	MONDO:0005091	MONDO:0100096

Clinical trials

Total trials: 15.

Phase distribution

Phase	Trials
Not specified	5
PHASE3	3
PHASE1	3
PHASE2/PHASE3	2
PHASE4	1
PHASE2	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT05697055	PHASE4	UNKNOWN	A Study of Efficacy and Safety of Azvudine vs. Nirmatrelvir-Ritonavir in the Treatment of COVID-19 Infection
NCT05689034	PHASE2/PHASE3	RECRUITING	Multicenter Randomized Double-blind Placebo-controlled Study to Investigate Azvudine in Symptomatic Adults With COVID-19 at Increased Risk of Progressing to Severe Illness
NCT07307586	PHASE3	RECRUITING	A Small Sample Prospective Clinical Study of Azvudine Tablets to Promote Clinical Cure in Patients With Chronic Hepatitis B
NCT04668235	PHASE3	COMPLETED	Study on Safety and Clinical Efficacy of AZVUDINE in COVID-19 Patients (SARS-CoV-2 Infected)
NCT05033145	PHASE3	COMPLETED	Study on Safety and Clinical Efficacy of AZVUDINE in Initial Stage COVID-19 Patients (SARS-CoV-2 Infected)
NCT05633433	PHASE2/PHASE3	UNKNOWN	Evaluate the Efficacy and Safety of Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Covid-19
NCT05682599	PHASE2	UNKNOWN	Evaluate Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Covid-19 in China
NCT07001436	PHASE1	RECRUITING	A Pharmacokinetics and Safety Study of Azvudine Tablets in Subjects With Mild-To-Moderate GFR Decline in Renal Insufficiency and in Healthy Subjects
NCT06991634	PHASE1	COMPLETED	A Study to Evaluate the Pharmacokinetics and Safety of Azvudine Tablets in Healthy Adult Subjects and Healthy Elderly Subjects
NCT07002242	PHASE1	COMPLETED	A Clinical Study of the Interactions Between Azvudine Tablets (FNC) and Aluvia
NCT05621993	Not specified	UNKNOWN	An Observational, Ambispective Cohort Study of Azvudine in the Treatment of Patients With COVID-19 Pneumonia
NCT05642910	Not specified	UNKNOWN	The Efficacy of Azvudine and Paxlovid in High-risk Patients With COVID-19: A Prospective Randomized Controlled Trial
NCT05675748	Not specified	UNKNOWN	Real-world Study Evaluating the Efficacy and Safety of Azvudine in Nursing Home Patients
NCT06006611	Not specified	UNKNOWN	Risk Factors for Severe Disease in Hospitalized Patients With COVID-19 and the Effect of Azvudine Treatment: a Retrospective Cohort Study
NCT06349655	Not specified	COMPLETED	The Real-world Clinical Study of Azvudine Tablets in the Treatment of COVID-19

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).