Last reviewed 2026-04-19 · How we verify

IBD98-M without HA

Holy Stone Healthcare Co., Ltd · Phase 1 active Small molecule

IBD98-M without HA is a Small molecule drug developed by Holy Stone Healthcare Co., Ltd. It is currently in Phase 1 development. Also known as: IBD98-M without HA: Mesalamine 400 mg.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% 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	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+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	IBD98-M without HA
Also known as	IBD98-M without HA: Mesalamine 400 mg
Sponsor	Holy Stone Healthcare Co., Ltd
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Pharmacokinetics of IBD98-M 400mg-57.5/Day in Healthy Volunteers (PHASE1)

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:

IBD98-M without HA CI brief — competitive landscape report
IBD98-M without HA updates RSS · CI watch RSS
Holy Stone Healthcare Co., Ltd portfolio CI

Frequently asked questions about IBD98-M without HA

What is IBD98-M without HA?

IBD98-M without HA is a Small molecule drug developed by Holy Stone Healthcare Co., Ltd.

Who makes IBD98-M without HA?

IBD98-M without HA is developed by Holy Stone Healthcare Co., Ltd (see full Holy Stone Healthcare Co., Ltd pipeline at /company/holy-stone-healthcare-co-ltd).

Is IBD98-M without HA also known as anything else?

IBD98-M without HA is also known as IBD98-M without HA: Mesalamine 400 mg.

What development phase is IBD98-M without HA in?

IBD98-M without HA is in Phase 1.

Manufacturer: Holy Stone Healthcare Co., Ltd — full pipeline
Also known as: IBD98-M without HA: Mesalamine 400 mg

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