Last reviewed 2026-05-30 · How we verify

Bicanorm

University of Freiburg · Phase 1 active Small molecule ✓ Verified May 2026 Quality 0/100

Bicanorm is a Small molecule drug developed by University of Freiburg. It is currently in Phase 1 development. Also known as: Sodium bicarbonate.

Bicanorm is being studied in a clinical trial for the treatment of Acute Myeloid Leukemia in relapse. The trial, NCT04321161, is analyzing the effects of Bicanorm on T cell metabolism in patients with relapsed AML who are receiving donor lymphocyte infusions.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% 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	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+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	Bicanorm
Also known as	Sodium bicarbonate
Sponsor	University of Freiburg
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Analysis of T Cell Metabolism and Immune Phenotype in Relapsed Acute Myeloid Leukemia Patients Receiving Donor Lymphocyte Infusions and Bicanorm (Sodium Bicarbonate) (EARLY/Phase 1)

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:

Bicanorm CI brief — competitive landscape report
Bicanorm updates RSS · CI watch RSS
University of Freiburg portfolio CI

Frequently asked questions about Bicanorm

What is Bicanorm?

Bicanorm is a Small molecule drug developed by University of Freiburg.

Who makes Bicanorm?

Bicanorm is developed by University of Freiburg (see full University of Freiburg pipeline at /company/university-of-freiburg).

Is Bicanorm also known as anything else?

Bicanorm is also known as Sodium bicarbonate.

What development phase is Bicanorm in?

Bicanorm is in Phase 1.

Manufacturer: University of Freiburg — full pipeline
Therapeutic area: All drugs in Other
Also known as: Sodium bicarbonate

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