Last reviewed 2026-04-23 · How we verify

APD515

Acacia Pharma Ltd · Phase 2 active Small molecule

APD515 is a NK1 receptor antagonist Small molecule drug developed by Acacia Pharma Ltd. It is currently in Phase 2 development for Chemotherapy-induced nausea and vomiting (CINV), Postoperative nausea and vomiting (PONV).

APD515 is a selective antagonist of the neurokinin-1 (NK1) receptor that reduces nausea and vomiting by blocking substance P signaling in the chemoreceptor trigger zone and vomiting center.

APD515 is a selective antagonist of the neurokinin-1 (NK1) receptor that reduces nausea and vomiting by blocking substance P signaling in the chemoreceptor trigger zone and vomiting center. Used for Chemotherapy-induced nausea and vomiting (CINV), Postoperative nausea and vomiting (PONV).

Likelihood of approval

13.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Oncology Phase 2 attrition -2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	APD515
Sponsor	Acacia Pharma Ltd
Drug class	NK1 receptor antagonist
Target	NK1 receptor (neurokinin-1 receptor)
Modality	Small molecule
Therapeutic area	Oncology / Gastroenterology
Phase	Phase 2

Mechanism of action

APD515 crosses the blood-brain barrier to antagonize NK1 receptors, which are involved in the emetic pathway. By blocking substance P, a key neurotransmitter in nausea and vomiting, the drug provides antiemetic effects. This mechanism is particularly relevant for chemotherapy-induced nausea and vomiting (CINV) and postoperative nausea and vomiting (PONV).

Approved indications

Chemotherapy-induced nausea and vomiting (CINV)
Postoperative nausea and vomiting (PONV)

Common side effects

Headache
Constipation
Fatigue

Key clinical trials

Proof-of-concept (PoC) Study of APD515 (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:

APD515 CI brief — competitive landscape report
APD515 updates RSS · CI watch RSS
Acacia Pharma Ltd portfolio CI

Frequently asked questions about APD515

What is APD515?

APD515 is a NK1 receptor antagonist drug developed by Acacia Pharma Ltd, indicated for Chemotherapy-induced nausea and vomiting (CINV), Postoperative nausea and vomiting (PONV).

How does APD515 work?

APD515 is a selective antagonist of the neurokinin-1 (NK1) receptor that reduces nausea and vomiting by blocking substance P signaling in the chemoreceptor trigger zone and vomiting center.

What is APD515 used for?

APD515 is indicated for Chemotherapy-induced nausea and vomiting (CINV), Postoperative nausea and vomiting (PONV).

Who makes APD515?

APD515 is developed by Acacia Pharma Ltd (see full Acacia Pharma Ltd pipeline at /company/acacia-pharma-ltd).

What drug class is APD515 in?

APD515 belongs to the NK1 receptor antagonist class. See all NK1 receptor antagonist drugs at /class/nk1-receptor-antagonist.

What development phase is APD515 in?

APD515 is in Phase 2.

What are the side effects of APD515?

Common side effects of APD515 include Headache, Constipation, Fatigue.

What does APD515 target?

APD515 targets NK1 receptor (neurokinin-1 receptor) and is a NK1 receptor antagonist.

Drug class: All NK1 receptor antagonist drugs
Target: All drugs targeting NK1 receptor (neurokinin-1 receptor)
Manufacturer: Acacia Pharma Ltd — full pipeline
Therapeutic area: All drugs in Oncology / Gastroenterology
Indication: Drugs for Chemotherapy-induced nausea and vomiting (CINV)
Indication: Drugs for Postoperative nausea and vomiting (PONV)

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