Last reviewed 2026-04-22 · How we verify

Cytoflavin® enteric-coated tablet

POLYSAN Scientific & Technological Pharmaceutical Company · Phase 3 active Small molecule

Cytoflavin® enteric-coated tablet is a Metabolic enhancer / Antioxidant combination Small molecule drug developed by POLYSAN Scientific & Technological Pharmaceutical Company. It is currently in Phase 3 development for Acute ischemic stroke, Chronic cerebrovascular insufficiency, Metabolic encephalopathy. Also known as: Inosine+Nicotinamide+Riboflavin+Succinic Acid tablet.

Cytoflavin is a combination drug that enhances cellular energy metabolism and reduces oxidative stress through its active components.

Cytoflavin is a combination drug that enhances cellular energy metabolism and reduces oxidative stress through its active components. Used for Acute ischemic stroke, Chronic cerebrovascular insufficiency, Metabolic encephalopathy.

Likelihood of approval

55.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
CNS / neurology attrition -3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Cytoflavin® enteric-coated tablet
Also known as	Inosine+Nicotinamide+Riboflavin+Succinic Acid tablet
Sponsor	POLYSAN Scientific & Technological Pharmaceutical Company
Drug class	Metabolic enhancer / Antioxidant combination
Modality	Small molecule
Therapeutic area	Neurology / Metabolic disorders
Phase	Phase 3

Mechanism of action

Cytoflavin contains succinic acid (a Krebs cycle intermediate), riboflavin (vitamin B2), and nicotinamide (vitamin B3), which work synergistically to improve mitochondrial function and ATP production. This combination helps restore cellular energy metabolism and provides antioxidant protection, particularly in conditions characterized by metabolic dysfunction or hypoxia.

Approved indications

Acute ischemic stroke
Chronic cerebrovascular insufficiency
Metabolic encephalopathy

Common side effects

Gastrointestinal disturbances
Headache
Dizziness

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Cytoflavin® enteric-coated tablet CI brief — competitive landscape report
Cytoflavin® enteric-coated tablet updates RSS · CI watch RSS
POLYSAN Scientific & Technological Pharmaceutical Company portfolio CI

Frequently asked questions about Cytoflavin® enteric-coated tablet

What is Cytoflavin® enteric-coated tablet?

Cytoflavin® enteric-coated tablet is a Metabolic enhancer / Antioxidant combination drug developed by POLYSAN Scientific & Technological Pharmaceutical Company, indicated for Acute ischemic stroke, Chronic cerebrovascular insufficiency, Metabolic encephalopathy.

How does Cytoflavin® enteric-coated tablet work?

Cytoflavin is a combination drug that enhances cellular energy metabolism and reduces oxidative stress through its active components.

What is Cytoflavin® enteric-coated tablet used for?

Cytoflavin® enteric-coated tablet is indicated for Acute ischemic stroke, Chronic cerebrovascular insufficiency, Metabolic encephalopathy.

Who makes Cytoflavin® enteric-coated tablet?

Cytoflavin® enteric-coated tablet is developed by POLYSAN Scientific & Technological Pharmaceutical Company (see full POLYSAN Scientific & Technological Pharmaceutical Company pipeline at /company/polysan-scientific-technological-pharmaceutical-company).

Is Cytoflavin® enteric-coated tablet also known as anything else?

Cytoflavin® enteric-coated tablet is also known as Inosine+Nicotinamide+Riboflavin+Succinic Acid tablet.

What drug class is Cytoflavin® enteric-coated tablet in?

Cytoflavin® enteric-coated tablet belongs to the Metabolic enhancer / Antioxidant combination class. See all Metabolic enhancer / Antioxidant combination drugs at /class/metabolic-enhancer-antioxidant-combination.

What development phase is Cytoflavin® enteric-coated tablet in?

Cytoflavin® enteric-coated tablet is in Phase 3.

What are the side effects of Cytoflavin® enteric-coated tablet?

Common side effects of Cytoflavin® enteric-coated tablet include Gastrointestinal disturbances, Headache, Dizziness.

Drug class: All Metabolic enhancer / Antioxidant combination drugs
Manufacturer: POLYSAN Scientific & Technological Pharmaceutical Company — full pipeline
Therapeutic area: All drugs in Neurology / Metabolic disorders
Indication: Drugs for Acute ischemic stroke
Indication: Drugs for Chronic cerebrovascular insufficiency
Indication: Drugs for Metabolic encephalopathy
Also known as: Inosine+Nicotinamide+Riboflavin+Succinic Acid tablet

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing