Last reviewed 2026-06-01 · How we verify

SPK-8011QQ

Hoffmann-La Roche · Phase 1 active Small molecule ✓ Verified Jun 2026

SPK-8011QQ is a Small molecule drug developed by Hoffmann-La Roche. It is currently in Phase 1 development. Also known as: RO7878488.

SPK-8011QQ is a small molecule being studied in a Phase 2b clinical trial for the treatment of Hemophilia A. The trial, NCT07226206, is sponsored by Hoffmann-La Roche and aims to evaluate the efficacy of SPK-8011QQ in adults with severe or moderately severe Hemophilia A.

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
Hoffmann-La Roche 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	SPK-8011QQ
Also known as	RO7878488
Sponsor	Hoffmann-La Roche
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Gene Therapy Study of SPK-8011QQ in Adults With Severe or Moderately Severe Hemophilia A (PHASE1, PHASE2)

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:

SPK-8011QQ CI brief — competitive landscape report
SPK-8011QQ updates RSS · CI watch RSS
Hoffmann-La Roche portfolio CI

Frequently asked questions about SPK-8011QQ

What is SPK-8011QQ?

SPK-8011QQ is a Small molecule drug developed by Hoffmann-La Roche.

Who makes SPK-8011QQ?

SPK-8011QQ is developed by Hoffmann-La Roche (see full Hoffmann-La Roche pipeline at /company/roche).

Is SPK-8011QQ also known as anything else?

SPK-8011QQ is also known as RO7878488.

What development phase is SPK-8011QQ in?

SPK-8011QQ is in Phase 1.

Manufacturer: Hoffmann-La Roche — full pipeline
Also known as: RO7878488

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