Last reviewed 2026-06-02 · How we verify

Letrozol step up dose

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh · Phase 3 active Small molecule Under review

Letrozol step up dose is a Aromatase inhibitor Small molecule drug developed by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh. It is currently in Phase 3 development for Hormone receptor-positive, HER2-negative breast cancer in postmenopausal women (adjuvant or metastatic setting).

Letrozole is an aromatase inhibitor that blocks the conversion of androgens to estrogen, reducing circulating estrogen levels in postmenopausal women.

Letrozole is a small molecule used to treat conditions such as Polycystic Ovarian Syndrome (PCOS) and infertility, particularly in women with anovulation. It is administered through a step-up dose protocol, which involves increasing the dosage of letrozole over time, as an alternative to a conventional fixed dose.

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	Letrozol step up dose
Sponsor	Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Drug class	Aromatase inhibitor
Target	Aromatase (CYP19A1)
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

Letrozole selectively inhibits the aromatase enzyme (CYP19A1), which catalyzes the final step of estrogen biosynthesis in peripheral tissues. By reducing estrogen availability, it suppresses the growth of estrogen-dependent breast cancer cells. The 'step up dose' formulation likely refers to a dose-escalation protocol being evaluated in this Phase 3 trial.

Approved indications

Hormone receptor-positive, HER2-negative breast cancer in postmenopausal women (adjuvant or metastatic setting)

Common side effects

Hot flashes
Arthralgia/joint pain
Fatigue
Headache
Nausea
Osteoporosis/bone loss
Elevated cholesterol

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:

Letrozol step up dose CI brief — competitive landscape report
Letrozol step up dose updates RSS · CI watch RSS
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh portfolio CI

Frequently asked questions about Letrozol step up dose

What is Letrozol step up dose?

Letrozol step up dose is a Aromatase inhibitor drug developed by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh, indicated for Hormone receptor-positive, HER2-negative breast cancer in postmenopausal women (adjuvant or metastatic setting).

How does Letrozol step up dose work?

Letrozole is an aromatase inhibitor that blocks the conversion of androgens to estrogen, reducing circulating estrogen levels in postmenopausal women.

What is Letrozol step up dose used for?

Letrozol step up dose is indicated for Hormone receptor-positive, HER2-negative breast cancer in postmenopausal women (adjuvant or metastatic setting).

Who makes Letrozol step up dose?

Letrozol step up dose is developed by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh (see full Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh pipeline at /company/bangabandhu-sheikh-mujib-medical-university-dhaka-bangladesh).

What drug class is Letrozol step up dose in?

Letrozol step up dose belongs to the Aromatase inhibitor class. See all Aromatase inhibitor drugs at /class/aromatase-inhibitor.

What development phase is Letrozol step up dose in?

Letrozol step up dose is in Phase 3.

What are the side effects of Letrozol step up dose?

Common side effects of Letrozol step up dose include Hot flashes, Arthralgia/joint pain, Fatigue, Headache, Nausea, Osteoporosis/bone loss.

What does Letrozol step up dose target?

Letrozol step up dose targets Aromatase (CYP19A1) and is a Aromatase inhibitor.

Drug class: All Aromatase inhibitor drugs
Target: All drugs targeting Aromatase (CYP19A1)
Manufacturer: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Hormone receptor-positive, HER2-negative breast cancer in postmenopausal women (adjuvant or metastatic setting)

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