Last reviewed 2026-05-15 · How we verify

Conventional fixed dose letrozole

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

Conventional fixed dose letrozole 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 and metastatic settings), Extended adjuvant therapy following tamoxifen in postmenopausal women with early-stage breast cancer.

Letrozole is an aromatase inhibitor that blocks the conversion of androgens to estrogen, reducing circulating estrogen levels in postmenopausal women with hormone receptor-positive breast cancer.

Letrozole is an aromatase inhibitor that blocks the conversion of androgens to estrogen, reducing circulating estrogen levels in postmenopausal women with hormone receptor-positive breast cancer. Used for Hormone receptor-positive, HER2-negative breast cancer in postmenopausal women (adjuvant and metastatic settings), Extended adjuvant therapy following tamoxifen in postmenopausal women with early-stage breast cancer.

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	Conventional fixed dose letrozole
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 aromatase, the enzyme responsible for the final step of estrogen synthesis in postmenopausal women. By reducing estrogen availability, it slows or stops the growth of estrogen-dependent breast cancer cells. This mechanism is particularly effective in hormone receptor-positive breast cancers where estrogen signaling drives tumor proliferation.

Approved indications

Hormone receptor-positive, HER2-negative breast cancer in postmenopausal women (adjuvant and metastatic settings)
Extended adjuvant therapy following tamoxifen in postmenopausal women with early-stage breast cancer

Common side effects

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

Key clinical trials

Letrozole Step up Protocol for Ovulation Induction in Infertile Women With Polycystic Ovary Syndrome (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:

Conventional fixed dose letrozole CI brief — competitive landscape report
Conventional fixed dose letrozole updates RSS · CI watch RSS
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh portfolio CI

Frequently asked questions about Conventional fixed dose letrozole

What is Conventional fixed dose letrozole?

Conventional fixed dose letrozole 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 and metastatic settings), Extended adjuvant therapy following tamoxifen in postmenopausal women with early-stage breast cancer.

How does Conventional fixed dose letrozole work?

Letrozole is an aromatase inhibitor that blocks the conversion of androgens to estrogen, reducing circulating estrogen levels in postmenopausal women with hormone receptor-positive breast cancer.

What is Conventional fixed dose letrozole used for?

Conventional fixed dose letrozole is indicated for Hormone receptor-positive, HER2-negative breast cancer in postmenopausal women (adjuvant and metastatic settings), Extended adjuvant therapy following tamoxifen in postmenopausal women with early-stage breast cancer.

Who makes Conventional fixed dose letrozole?

Conventional fixed dose letrozole 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 Conventional fixed dose letrozole in?

Conventional fixed dose letrozole belongs to the Aromatase inhibitor class. See all Aromatase inhibitor drugs at /class/aromatase-inhibitor.

What development phase is Conventional fixed dose letrozole in?

Conventional fixed dose letrozole is in Phase 3.

What are the side effects of Conventional fixed dose letrozole?

Common side effects of Conventional fixed dose letrozole include Hot flashes, Arthralgia/joint pain, Fatigue, Headache, Nausea, Osteoporosis/bone loss.

What does Conventional fixed dose letrozole target?

Conventional fixed dose letrozole 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 and metastatic settings)
Indication: Drugs for Extended adjuvant therapy following tamoxifen in postmenopausal women with early-stage breast cancer

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