Last reviewed 2026-05-29 · How we verify

DLBS1442 100

Dexa Medica Group · Phase 2 active Small molecule ✓ Verified May 2026 Quality 0/100

DLBS1442 100 is a Small molecule drug developed by Dexa Medica Group. It is currently in Phase 2 development. Also known as: Dismeno 100.

DLBS1442 100 is being studied as a potential treatment for patients with suspected endometriosis experiencing moderate or severe pain. The study is comparing the effectiveness of DLBS1442 100 to mefenamic acid in reducing pain in these patients.

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	DLBS1442 100
Also known as	Dismeno 100
Sponsor	Dexa Medica Group
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

DLBS1442 for The Treatment of Pain in Patients Suspected Endometriosis (PHASE2, 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:

DLBS1442 100 CI brief — competitive landscape report
DLBS1442 100 updates RSS · CI watch RSS
Dexa Medica Group portfolio CI

Frequently asked questions about DLBS1442 100

What is DLBS1442 100?

DLBS1442 100 is a Small molecule drug developed by Dexa Medica Group.

Who makes DLBS1442 100?

DLBS1442 100 is developed by Dexa Medica Group (see full Dexa Medica Group pipeline at /company/dexa-medica-group).

Is DLBS1442 100 also known as anything else?

DLBS1442 100 is also known as Dismeno 100.

What development phase is DLBS1442 100 in?

DLBS1442 100 is in Phase 2.

Manufacturer: Dexa Medica Group — full pipeline
Also known as: Dismeno 100

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