Last reviewed 2026-04-23 · How we verify

Aspirin Aspro

Bayer · Phase 1 active Small molecule

Aspirin Aspro is a Nonsteroidal anti-inflammatory drug (NSAID) Small molecule drug developed by Bayer. It is currently in Phase 1 development for Headache, Fever reduction, Pain relief.

Inhibits COX-1 and COX-2 enzymes

Inhibits COX-1 and COX-2 enzymes Used for Headache, Fever reduction, Pain relief.

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
Bayer 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	Aspirin Aspro
Sponsor	Bayer
Drug class	Nonsteroidal anti-inflammatory drug (NSAID)
Target	COX-1 and COX-2
Modality	Small molecule
Therapeutic area	Oncology, Cardiovascular, Neurology
Phase	Phase 1

Mechanism of action

Aspirin works by blocking the production of prostaglandins, which are hormone-like substances that cause pain, inflammation, and fever.

Approved indications

Headache, Fever reduction, Pain relief

Common side effects

Gastrointestinal upset
Bleeding
Allergic reactions

Key clinical trials

Pharmacokinetic Study Comparing Aspirin and Effervescent Aspirin (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:

Aspirin Aspro CI brief — competitive landscape report
Aspirin Aspro updates RSS · CI watch RSS
Bayer portfolio CI

Frequently asked questions about Aspirin Aspro

What is Aspirin Aspro?

Aspirin Aspro is a Nonsteroidal anti-inflammatory drug (NSAID) drug developed by Bayer, indicated for Headache, Fever reduction, Pain relief.

How does Aspirin Aspro work?

Inhibits COX-1 and COX-2 enzymes

What is Aspirin Aspro used for?

Aspirin Aspro is indicated for Headache, Fever reduction, Pain relief.

Who makes Aspirin Aspro?

Aspirin Aspro is developed by Bayer (see full Bayer pipeline at /company/bayer).

What drug class is Aspirin Aspro in?

Aspirin Aspro belongs to the Nonsteroidal anti-inflammatory drug (NSAID) class. See all Nonsteroidal anti-inflammatory drug (NSAID) drugs at /class/nonsteroidal-anti-inflammatory-drug-nsaid.

What development phase is Aspirin Aspro in?

Aspirin Aspro is in Phase 1.

What are the side effects of Aspirin Aspro?

Common side effects of Aspirin Aspro include Gastrointestinal upset, Bleeding, Allergic reactions.

What does Aspirin Aspro target?

Aspirin Aspro targets COX-1 and COX-2 and is a Nonsteroidal anti-inflammatory drug (NSAID).

Drug class: All Nonsteroidal anti-inflammatory drug (NSAID) drugs
Target: All drugs targeting COX-1 and COX-2
Manufacturer: Bayer — full pipeline
Therapeutic area: All drugs in Oncology, Cardiovascular, Neurology
Indication: Drugs for Headache, Fever reduction, Pain relief

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