Last reviewed 2026-04-20 · How we verify

Urofort (AMANOZINE)

Phase 2 active Small molecule

Urofort (generic name: AMANOZINE) is a drug. It is currently in Phase 2 development for Cobalamin deficiency, Pernicious anemia, Prevention of Vitamin B12 Deficiency.

Urofort works by providing a source of Cobalamin to the body, helping to address deficiencies and prevent related conditions.

Urofort (AMANOZINE) is a small molecule modality developed for the treatment of Cobalamin deficiency, Pernicious anemia, and Prevention of Vitamin B12 Deficiency. The current owner of Urofort is unknown. It is used to address deficiencies in Cobalamin, a crucial vitamin for the production of red blood cells. Urofort's commercial status is unclear, and its safety considerations are not well-documented. Further research is needed to fully understand its pharmacological properties and potential risks.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	AMANOZINE
Modality	Small molecule
Therapeutic area	Hematology
Phase	Phase 2

Mechanism of action

Think of Urofort like a supplement that helps your body get the Cobalamin it needs to make healthy red blood cells. Without enough Cobalamin, your body can't produce enough red blood cells, leading to anemia. Urofort helps fill this gap, supporting overall health and preventing related complications.

Approved indications

Cobalamin deficiency
Pernicious anemia
Prevention of Vitamin B12 Deficiency

Common side effects

No common side effects on file.

Competitive intelligence

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

Urofort CI brief — competitive landscape report
Urofort updates RSS · CI watch RSS

Frequently asked questions about Urofort

What is Urofort?

Urofort (AMANOZINE) is a Small molecule drug, indicated for Cobalamin deficiency, Pernicious anemia, Prevention of Vitamin B12 Deficiency.

How does Urofort work?

Urofort works by providing a source of Cobalamin to the body, helping to address deficiencies and prevent related conditions.

What is Urofort used for?

Urofort is indicated for Cobalamin deficiency, Pernicious anemia, Prevention of Vitamin B12 Deficiency.

What is the generic name of Urofort?

AMANOZINE is the generic (nonproprietary) name of Urofort.

What development phase is Urofort in?

Urofort is in Phase 2.

Therapeutic area: All drugs in Hematology
Indication: Drugs for Cobalamin deficiency
Indication: Drugs for Pernicious anemia
Indication: Drugs for Prevention of Vitamin B12 Deficiency

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