Last reviewed 2026-05-15 · How we verify

Amoxicillin Pulsatile Release Multiparticluate Sprinkle

Advancis Pharmaceutical Corporation · Phase 3 active Small molecule

Amoxicillin Pulsatile Release Multiparticluate Sprinkle is a Beta-lactam antibiotic (penicillin) Small molecule drug developed by Advancis Pharmaceutical Corporation. It is currently in Phase 3 development for Bacterial infections susceptible to amoxicillin (specific indications in Phase 3 development unknown).

Amoxicillin is a beta-lactam antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins, delivered via a pulsatile release multiparticulate sprinkle formulation for modified pharmacokinetics. Used for Bacterial infections susceptible to amoxicillin (specific indications in Phase 3 development unknown).

Likelihood of approval

60.3% 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).
Anti-infectives pathway favourability +2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.

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	Amoxicillin Pulsatile Release Multiparticluate Sprinkle
Sponsor	Advancis Pharmaceutical Corporation
Drug class	Beta-lactam antibiotic (penicillin)
Target	Penicillin-binding proteins (PBPs)
Modality	Small molecule
Therapeutic area	Infectious Disease
Phase	Phase 3

Mechanism of action

Amoxicillin works by disrupting peptidoglycan cross-linking in bacterial cell walls, leading to cell lysis and death. The pulsatile release multiparticulate sprinkle formulation is designed to deliver the drug in a controlled, time-dependent manner rather than continuous release, potentially optimizing therapeutic levels and reducing dosing frequency. This formulation approach may improve patient compliance and reduce gastrointestinal side effects.

Approved indications

Bacterial infections susceptible to amoxicillin (specific indications in Phase 3 development unknown)

Common side effects

Diarrhea
Nausea
Rash
Allergic reactions

Key clinical trials

APC-231 Once a Day (QD) for 7 Days vs. Penicillin Taken Four Times a Day (QID) in Pediatric Patients With Strep Throat (PHASE3)

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:

Amoxicillin Pulsatile Release Multiparticluate Sprinkle CI brief — competitive landscape report
Amoxicillin Pulsatile Release Multiparticluate Sprinkle updates RSS · CI watch RSS
Advancis Pharmaceutical Corporation portfolio CI

Frequently asked questions about Amoxicillin Pulsatile Release Multiparticluate Sprinkle

What is Amoxicillin Pulsatile Release Multiparticluate Sprinkle?

Amoxicillin Pulsatile Release Multiparticluate Sprinkle is a Beta-lactam antibiotic (penicillin) drug developed by Advancis Pharmaceutical Corporation, indicated for Bacterial infections susceptible to amoxicillin (specific indications in Phase 3 development unknown).

How does Amoxicillin Pulsatile Release Multiparticluate Sprinkle work?

What is Amoxicillin Pulsatile Release Multiparticluate Sprinkle used for?

Amoxicillin Pulsatile Release Multiparticluate Sprinkle is indicated for Bacterial infections susceptible to amoxicillin (specific indications in Phase 3 development unknown).

Who makes Amoxicillin Pulsatile Release Multiparticluate Sprinkle?

Amoxicillin Pulsatile Release Multiparticluate Sprinkle is developed by Advancis Pharmaceutical Corporation (see full Advancis Pharmaceutical Corporation pipeline at /company/advancis-pharmaceutical-corporation).

What drug class is Amoxicillin Pulsatile Release Multiparticluate Sprinkle in?

Amoxicillin Pulsatile Release Multiparticluate Sprinkle belongs to the Beta-lactam antibiotic (penicillin) class. See all Beta-lactam antibiotic (penicillin) drugs at /class/beta-lactam-antibiotic-penicillin.

What development phase is Amoxicillin Pulsatile Release Multiparticluate Sprinkle in?

Amoxicillin Pulsatile Release Multiparticluate Sprinkle is in Phase 3.

What are the side effects of Amoxicillin Pulsatile Release Multiparticluate Sprinkle?

Common side effects of Amoxicillin Pulsatile Release Multiparticluate Sprinkle include Diarrhea, Nausea, Rash, Allergic reactions.

What does Amoxicillin Pulsatile Release Multiparticluate Sprinkle target?

Amoxicillin Pulsatile Release Multiparticluate Sprinkle targets Penicillin-binding proteins (PBPs) and is a Beta-lactam antibiotic (penicillin).

Drug class: All Beta-lactam antibiotic (penicillin) drugs
Target: All drugs targeting Penicillin-binding proteins (PBPs)
Manufacturer: Advancis Pharmaceutical Corporation — full pipeline
Therapeutic area: All drugs in Infectious Disease
Indication: Drugs for Bacterial infections susceptible to amoxicillin (specific indications in Phase 3 development unknown)

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