Last reviewed 2026-04-23 · How we verify

Docetaxel + Plinabulin (DP)

BeyondSpring Pharmaceuticals Inc. · Phase 3 active Small molecule

Docetaxel + Plinabulin (DP) is a Taxane + microtubule-disrupting agent combination Small molecule drug developed by BeyondSpring Pharmaceuticals Inc.. It is currently in Phase 3 development for Metastatic non-small cell lung cancer (Phase 3), Advanced solid tumors (investigational). Also known as: BPI-2358, NPI-2358.

Docetaxel inhibits microtubule depolymerization to arrest cell division, while plinabulin disrupts microtubule dynamics and suppresses neutrophil migration to enhance chemotherapy efficacy and reduce chemotherapy-induced neutropenia.

Likelihood of approval

61.3% 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.

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	Docetaxel + Plinabulin (DP)
Also known as	BPI-2358, NPI-2358
Sponsor	BeyondSpring Pharmaceuticals Inc.
Drug class	Taxane + microtubule-disrupting agent combination
Target	Microtubules (β-tubulin); immune cell migration pathways
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

Docetaxel is a taxane that stabilizes microtubules and prevents cancer cell division. Plinabulin is a vascular disrupting agent that destabilizes microtubules in endothelial cells and immune cells, improving drug delivery to tumors while simultaneously reducing the severity of chemotherapy-induced peripheral neuropathy and neutropenia through immunomodulatory effects on neutrophil function.

Approved indications

Metastatic non-small cell lung cancer (Phase 3)
Advanced solid tumors (investigational)

Common side effects

Neutropenia
Peripheral neuropathy
Fatigue
Nausea/vomiting
Alopecia

Key clinical trials

Docetaxel + Plinabulin Compared to Docetaxel + Placebo in Patients With Advanced NSCLC (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:

Docetaxel + Plinabulin (DP) CI brief — competitive landscape report
Docetaxel + Plinabulin (DP) updates RSS · CI watch RSS
BeyondSpring Pharmaceuticals Inc. portfolio CI

Frequently asked questions about Docetaxel + Plinabulin (DP)

What is Docetaxel + Plinabulin (DP)?

Docetaxel + Plinabulin (DP) is a Taxane + microtubule-disrupting agent combination drug developed by BeyondSpring Pharmaceuticals Inc., indicated for Metastatic non-small cell lung cancer (Phase 3), Advanced solid tumors (investigational).

How does Docetaxel + Plinabulin (DP) work?

What is Docetaxel + Plinabulin (DP) used for?

Docetaxel + Plinabulin (DP) is indicated for Metastatic non-small cell lung cancer (Phase 3), Advanced solid tumors (investigational).

Who makes Docetaxel + Plinabulin (DP)?

Docetaxel + Plinabulin (DP) is developed by BeyondSpring Pharmaceuticals Inc. (see full BeyondSpring Pharmaceuticals Inc. pipeline at /company/beyondspring-pharmaceuticals-inc).

Is Docetaxel + Plinabulin (DP) also known as anything else?

Docetaxel + Plinabulin (DP) is also known as BPI-2358, NPI-2358.

What drug class is Docetaxel + Plinabulin (DP) in?

Docetaxel + Plinabulin (DP) belongs to the Taxane + microtubule-disrupting agent combination class. See all Taxane + microtubule-disrupting agent combination drugs at /class/taxane-microtubule-disrupting-agent-combination.

What development phase is Docetaxel + Plinabulin (DP) in?

Docetaxel + Plinabulin (DP) is in Phase 3.

What are the side effects of Docetaxel + Plinabulin (DP)?

Common side effects of Docetaxel + Plinabulin (DP) include Neutropenia, Peripheral neuropathy, Fatigue, Nausea/vomiting, Alopecia.

What does Docetaxel + Plinabulin (DP) target?

Docetaxel + Plinabulin (DP) targets Microtubules (β-tubulin); immune cell migration pathways and is a Taxane + microtubule-disrupting agent combination.

Drug class: All Taxane + microtubule-disrupting agent combination drugs
Target: All drugs targeting Microtubules (β-tubulin); immune cell migration pathways
Manufacturer: BeyondSpring Pharmaceuticals Inc. — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Metastatic non-small cell lung cancer (Phase 3)
Indication: Drugs for Advanced solid tumors (investigational)
Also known as: BPI-2358, NPI-2358

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