Last reviewed 2026-05-24 · How we verify

Dydrogesterone Pill

National University of Malaysia · Phase 1 active Small molecule ✓ Verified May 2026 Quality 0/100

Dydrogesterone Pill is a Small molecule drug developed by National University of Malaysia. It is currently in Phase 1 development.

Dydrogesterone is a small molecule that acts as a progesterone receptor agonist. It is used in fertility treatments, such as IVF, to stimulate oocyte maturation and improve clinical pregnancy rates.

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	Dydrogesterone Pill
Sponsor	National University of Malaysia
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

nausea and abdominal distention
headache
pelvic pain

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Dydrogesterone Pill CI brief — competitive landscape report
Dydrogesterone Pill updates RSS · CI watch RSS
National University of Malaysia portfolio CI

Frequently asked questions about Dydrogesterone Pill

What is Dydrogesterone Pill?

Dydrogesterone Pill is a Small molecule drug developed by National University of Malaysia.

Who makes Dydrogesterone Pill?

Dydrogesterone Pill is developed by National University of Malaysia (see full National University of Malaysia pipeline at /company/national-university-of-malaysia).

What development phase is Dydrogesterone Pill in?

Dydrogesterone Pill is in Phase 1.

What are the side effects of Dydrogesterone Pill?

Common side effects of Dydrogesterone Pill include nausea and abdominal distention, headache, pelvic pain.

Manufacturer: National University of Malaysia — full pipeline

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