Last reviewed 2026-05-23 · How we verify

Spesolimap

Boehringer Ingelheim · Phase 1 active Small molecule ✓ Verified May 2026 Quality 25/100

Spesolimap is a Small molecule drug developed by Boehringer Ingelheim. It is currently in Phase 1 development. Also known as: BI 655130.

Spesolimap, also known as BI 655130, is a drug being tested in a Phase I trial to assess its pharmacokinetics and safety in healthy Chinese volunteers. The trial is evaluating how different doses of Spesolimap are taken up in the body after being administered via subcutaneous or intravenous injection.

Likelihood of approval

12.6% 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).
Big-pharma sponsor +3.0pp
Boehringer Ingelheim is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

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	Spesolimap
Also known as	BI 655130
Sponsor	Boehringer Ingelheim
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

Dermatitis atopic
Headache
Folliculitis
Nasopharyngitis
Anxiety
Injection site erythema
Injection site haemorrhage
Eye pruritus
Abdominal distension
Nausea
Beta haemolytic streptococcal infection
Conjunctivitis

Key clinical trials

A Trial in Healthy Chinese Volunteers to Test How Different Doses of BI 655130 Are Taken up in the Body (PHASE1)

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:

Spesolimap CI brief — competitive landscape report
Spesolimap updates RSS · CI watch RSS
Boehringer Ingelheim portfolio CI

Frequently asked questions about Spesolimap

What is Spesolimap?

Spesolimap is a Small molecule drug developed by Boehringer Ingelheim.

Who makes Spesolimap?

Spesolimap is developed by Boehringer Ingelheim (see full Boehringer Ingelheim pipeline at /company/boehringer-ingelheim).

Is Spesolimap also known as anything else?

Spesolimap is also known as BI 655130.

What development phase is Spesolimap in?

Spesolimap is in Phase 1.

What are the side effects of Spesolimap?

Common side effects of Spesolimap include Dermatitis atopic, Headache, Folliculitis, Nasopharyngitis, Anxiety, Injection site erythema.

Manufacturer: Boehringer Ingelheim — full pipeline
Therapeutic area: All drugs in Other
Also known as: BI 655130

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