Last reviewed 2026-06-03 · How we verify

BEKINDA

RedHill Biopharma Limited · Phase 2 active Small molecule Under review

BEKINDA is a Serotonin 5-HT3 receptor antagonist Small molecule drug developed by RedHill Biopharma Limited. It is currently in Phase 2 development for Prevention of nausea and vomiting associated with chemotherapy and radiation therapy. Also known as: RHB-102 12 mg, Ondansetron Bimodal Release Tablet 12 mg.

Bekinda is a delayed-release tablet formulation of ondansetron, a serotonin 5-HT3 receptor antagonist.

BEKINDA is a medication that has been studied for the treatment of Irritable Bowel Syndrome With Diarrhea, Gastroenteritis, and Gastritis. It is a bimodal release tablet of ondansetron, which is a serotonin 5-HT3 receptor antagonist.

Likelihood of approval

15.3% 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).

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	BEKINDA
Also known as	RHB-102 12 mg, Ondansetron Bimodal Release Tablet 12 mg
Sponsor	RedHill Biopharma Limited
Drug class	Serotonin 5-HT3 receptor antagonist
Target	5-HT3 receptor
Modality	Small molecule
Therapeutic area	Gastroenterology
Phase	Phase 2

Mechanism of action

Serotonin 5-HT3 receptors are found in the central nervous system and the gastrointestinal tract. Activation of these receptors can cause nausea and vomiting. By blocking these receptors, Bekinda helps to prevent nausea and vomiting associated with chemotherapy and radiation therapy.

Approved indications

Prevention of nausea and vomiting associated with chemotherapy and radiation therapy

Common side effects

Headache
Diarrhea
Nausea
Vomiting
Fatigue

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:

BEKINDA CI brief — competitive landscape report
BEKINDA updates RSS · CI watch RSS
RedHill Biopharma Limited portfolio CI

Frequently asked questions about BEKINDA

What is BEKINDA?

BEKINDA is a Serotonin 5-HT3 receptor antagonist drug developed by RedHill Biopharma Limited, indicated for Prevention of nausea and vomiting associated with chemotherapy and radiation therapy.

How does BEKINDA work?

Bekinda is a delayed-release tablet formulation of ondansetron, a serotonin 5-HT3 receptor antagonist.

What is BEKINDA used for?

BEKINDA is indicated for Prevention of nausea and vomiting associated with chemotherapy and radiation therapy.

Who makes BEKINDA?

BEKINDA is developed by RedHill Biopharma Limited (see full RedHill Biopharma Limited pipeline at /company/redhill-biopharma-limited).

Is BEKINDA also known as anything else?

BEKINDA is also known as RHB-102 12 mg, Ondansetron Bimodal Release Tablet 12 mg.

What drug class is BEKINDA in?

BEKINDA belongs to the Serotonin 5-HT3 receptor antagonist class. See all Serotonin 5-HT3 receptor antagonist drugs at /class/serotonin-5-ht3-receptor-antagonist.

What development phase is BEKINDA in?

BEKINDA is in Phase 2.

What are the side effects of BEKINDA?

Common side effects of BEKINDA include Headache, Diarrhea, Nausea, Vomiting, Fatigue.

What does BEKINDA target?

BEKINDA targets 5-HT3 receptor and is a Serotonin 5-HT3 receptor antagonist.

Drug class: All Serotonin 5-HT3 receptor antagonist drugs
Target: All drugs targeting 5-HT3 receptor
Manufacturer: RedHill Biopharma Limited — full pipeline
Therapeutic area: All drugs in Gastroenterology
Indication: Drugs for Prevention of nausea and vomiting associated with chemotherapy and radiation therapy
Also known as: RHB-102 12 mg, Ondansetron Bimodal Release Tablet 12 mg

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