Last reviewed 2026-05-22 · How we verify

Bemiparine

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · Phase 2 active Small molecule ✓ Verified May 2026

Bemiparine is a Small molecule drug developed by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal. It is currently in Phase 2 development. Also known as: Hibor (3500UI/0,2ml).

Bemiparine is an oligosaccharide that activates Antithrombin-III, a mechanism that falls under the drug class of ACTIVATOR. It is being studied as a prophylactic antithrombotic agent in patients undergoing microvascular surgery for head and neck reconstruction.

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	Bemiparine
Also known as	Hibor (3500UI/0,2ml)
Sponsor	Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Use of Bemiparine as a Prophylactic Antithrombotic Agent, in Patients Undergoing Microsurgery for Head and Neck Reconstruction

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:

Bemiparine CI brief — competitive landscape report
Bemiparine updates RSS · CI watch RSS
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal portfolio CI

Frequently asked questions about Bemiparine

What is Bemiparine?

Bemiparine is a Small molecule drug developed by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal.

Who makes Bemiparine?

Bemiparine is developed by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal (see full Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal pipeline at /company/fundacion-para-la-investigacion-biomedica-del-hospital-universitario-ramon-y-caj).

Is Bemiparine also known as anything else?

Bemiparine is also known as Hibor (3500UI/0,2ml).

What development phase is Bemiparine in?

Bemiparine is in Phase 2.

Manufacturer: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal — full pipeline
Therapeutic area: All drugs in Other
Also known as: Hibor (3500UI/0,2ml)

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