Last reviewed 2026-05-31 · How we verify

MK-8521 150μg

Merck Sharp & Dohme LLC · Phase 1 active Small molecule ✓ Verified May 2026 Quality 18/100

MK-8521 150μg is a Small molecule drug developed by Merck Sharp & Dohme LLC. It is currently in Phase 1 development.

MK-8521 is a small molecule used in clinical trials for Type 2 Diabetes Mellitus. The specific dose of 150μg is not mentioned in the provided facts, but MK-8521 has been studied in doses of 35μg, 100μg, and 125μg in clinical trials.

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
Merck Sharp & Dohme LLC 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	MK-8521 150μg
Sponsor	Merck Sharp & Dohme LLC
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

Headache
Catheter site pain
Dizziness
Abdominal discomfort
Abdominal pain
Constipation
Diarrhoea
Dyspepsia
Nausea
Vomiting
Asthenia
Catheter site haematoma

Key clinical trials

A Single and Multiple-Dose Study of MK-8521 in Healthy and Obese Males (MK-8521-002) (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:

MK-8521 150μg CI brief — competitive landscape report
MK-8521 150μg updates RSS · CI watch RSS
Merck Sharp & Dohme LLC portfolio CI

Frequently asked questions about MK-8521 150μg

What is MK-8521 150μg?

MK-8521 150μg is a Small molecule drug developed by Merck Sharp & Dohme LLC.

Who makes MK-8521 150μg?

MK-8521 150μg is developed by Merck Sharp & Dohme LLC (see full Merck Sharp & Dohme LLC pipeline at /company/merck).

What development phase is MK-8521 150μg in?

MK-8521 150μg is in Phase 1.

What are the side effects of MK-8521 150μg?

Common side effects of MK-8521 150μg include Headache, Catheter site pain, Dizziness, Abdominal discomfort, Abdominal pain, Constipation.

Manufacturer: Merck Sharp & Dohme LLC — full pipeline

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