Last reviewed 2026-05-26 · How we verify

bipuvacain

Kristina Gemzell Danielsson · Phase 1 active Small molecule ✓ Verified May 2026

bipuvacain is a Small molecule drug developed by Kristina Gemzell Danielsson. It is currently in Phase 1 development. Also known as: (Marcain® 2,5mg/ml).

Bipuvacain is a medication that has been studied in a clinical trial for use in paracervical block during second-trimester medical abortion. The medication was compared to a control group receiving NaCl in a randomized controlled trial.

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	bipuvacain
Also known as	(Marcain® 2,5mg/ml)
Sponsor	Kristina Gemzell Danielsson
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

Paracervical Block During II-trimester Abortion (NA)

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:

bipuvacain CI brief — competitive landscape report
bipuvacain updates RSS · CI watch RSS
Kristina Gemzell Danielsson portfolio CI

Frequently asked questions about bipuvacain

What is bipuvacain?

bipuvacain is a Small molecule drug developed by Kristina Gemzell Danielsson.

Who makes bipuvacain?

bipuvacain is developed by Kristina Gemzell Danielsson (see full Kristina Gemzell Danielsson pipeline at /company/kristina-gemzell-danielsson).

Is bipuvacain also known as anything else?

bipuvacain is also known as (Marcain® 2,5mg/ml).

What development phase is bipuvacain in?

bipuvacain is in Phase 1.

Manufacturer: Kristina Gemzell Danielsson — full pipeline
Therapeutic area: All drugs in Other
Also known as: (Marcain® 2,5mg/ml)

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