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AFN-12520000

Affinium Pharmaceuticals, Ltd · Phase 2 active Small molecule

AFN-12520000 is a SGLT2 inhibitor Small molecule drug developed by Affinium Pharmaceuticals, Ltd. It is currently in Phase 2 development for Type 2 diabetes. Also known as: AFN-1252, API-1252.

AFN-12520000 is a small molecule that targets the SGLT2 receptor.

AFN-12520000 is a small molecule that targets the SGLT2 receptor. Used for Type 2 diabetes.

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 nameAFN-12520000
Also known asAFN-1252, API-1252
SponsorAffinium Pharmaceuticals, Ltd
Drug classSGLT2 inhibitor
TargetSGLT2
ModalitySmall molecule
Therapeutic areaDiabetes
PhasePhase 2

Mechanism of action

By inhibiting the SGLT2 receptor, AFN-12520000 reduces glucose reabsorption in the kidneys, leading to decreased blood glucose levels. This mechanism is particularly useful in the treatment of diabetes.

Approved indications

Common side effects

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.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about AFN-12520000

What is AFN-12520000?

AFN-12520000 is a SGLT2 inhibitor drug developed by Affinium Pharmaceuticals, Ltd, indicated for Type 2 diabetes.

How does AFN-12520000 work?

AFN-12520000 is a small molecule that targets the SGLT2 receptor.

What is AFN-12520000 used for?

AFN-12520000 is indicated for Type 2 diabetes.

Who makes AFN-12520000?

AFN-12520000 is developed by Affinium Pharmaceuticals, Ltd (see full Affinium Pharmaceuticals, Ltd pipeline at /company/affinium-pharmaceuticals-ltd).

Is AFN-12520000 also known as anything else?

AFN-12520000 is also known as AFN-1252, API-1252.

What drug class is AFN-12520000 in?

AFN-12520000 belongs to the SGLT2 inhibitor class. See all SGLT2 inhibitor drugs at /class/sglt2-inhibitor.

What development phase is AFN-12520000 in?

AFN-12520000 is in Phase 2.

What are the side effects of AFN-12520000?

Common side effects of AFN-12520000 include Increased risk of diabetic ketoacidosis.

What does AFN-12520000 target?

AFN-12520000 targets SGLT2 and is a SGLT2 inhibitor.

Related

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