Last reviewed 2026-05-24 · How we verify

Placebo for Aprepitant PFS

Merck Sharp & Dohme LLC · Phase 3 active Small molecule Under review

Placebo for Aprepitant PFS is a Small molecule drug developed by Merck Sharp & Dohme LLC. It is currently in Phase 3 development for Control arm in clinical trials for aprepitant efficacy and safety evaluation.

This is a placebo control with no active pharmacological mechanism.

Aprepitant is a medication used to prevent post-operative nausea and vomiting, as well as chemotherapy-induced nausea and vomiting, in children. In clinical trials, Aprepitant was compared to a placebo in studies evaluating its efficacy for these conditions.

Likelihood of approval

64.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Oncology Phase 3 boost +3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
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	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+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	Placebo for Aprepitant PFS
Sponsor	Merck Sharp & Dohme LLC
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

As a placebo for aprepitant, this formulation contains no active ingredient and serves as a control comparator in clinical trials. It is used to establish the efficacy and safety profile of aprepitant (a neurokinin-1 receptor antagonist used for chemotherapy-induced nausea and vomiting prevention) by comparison against an inert treatment.

Approved indications

Control arm in clinical trials for aprepitant efficacy and safety evaluation

Common side effects

No common side effects on file.

Key clinical trials

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:

Placebo for Aprepitant PFS CI brief — competitive landscape report
Placebo for Aprepitant PFS updates RSS · CI watch RSS
Merck Sharp & Dohme LLC portfolio CI

Frequently asked questions about Placebo for Aprepitant PFS

What is Placebo for Aprepitant PFS?

Placebo for Aprepitant PFS is a Small molecule drug developed by Merck Sharp & Dohme LLC, indicated for Control arm in clinical trials for aprepitant efficacy and safety evaluation.

How does Placebo for Aprepitant PFS work?

This is a placebo control with no active pharmacological mechanism.

What is Placebo for Aprepitant PFS used for?

Placebo for Aprepitant PFS is indicated for Control arm in clinical trials for aprepitant efficacy and safety evaluation.

Who makes Placebo for Aprepitant PFS?

Placebo for Aprepitant PFS is developed by Merck Sharp & Dohme LLC (see full Merck Sharp & Dohme LLC pipeline at /company/merck).

What development phase is Placebo for Aprepitant PFS in?

Placebo for Aprepitant PFS is in Phase 3.

Manufacturer: Merck Sharp & Dohme LLC — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Control arm in clinical trials for aprepitant efficacy and safety evaluation

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