Last reviewed 2026-04-23 · How we verify

Danazol Twice Weekly

Lumara Health, Inc. · Phase 2 active Small molecule

Danazol Twice Weekly is a Synthetic androgen Small molecule drug developed by Lumara Health, Inc.. It is currently in Phase 2 development for Hereditary angioedema (HAE), Endometriosis, Idiopathic thrombocytopenic purpura (ITP).

Danazol is a synthetic androgen that suppresses pituitary gonadotropins and has immunomodulatory effects, used to treat conditions involving abnormal bleeding or immune dysfunction.

Danazol is a synthetic androgen that suppresses pituitary gonadotropins and has immunomodulatory effects, used to treat conditions involving abnormal bleeding or immune dysfunction. Used for Hereditary angioedema (HAE), Endometriosis, Idiopathic thrombocytopenic purpura (ITP).

Likelihood of approval

16.3% 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).
Immunology slight uplift +1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.

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	Danazol Twice Weekly
Sponsor	Lumara Health, Inc.
Drug class	Synthetic androgen
Target	Androgen receptor; pituitary gonadotropin suppression
Modality	Small molecule
Therapeutic area	Hematology; Immunology; Gynecology
Phase	Phase 2

Mechanism of action

Danazol acts as a weak androgen and inhibits the midcycle surge of luteinizing hormone and follicle-stimulating hormone, thereby suppressing ovulation and menstruation. It also has direct effects on immune function and fibrinolysis, making it useful in conditions characterized by excessive bleeding or immune-mediated pathology. The twice-weekly formulation represents a modified dosing schedule of the established danazol molecule.

Approved indications

Hereditary angioedema (HAE)
Endometriosis
Idiopathic thrombocytopenic purpura (ITP)

Common side effects

Virilization (acne, hirsutism, voice deepening)
Menstrual irregularities
Hepatotoxicity
Lipid abnormalities
Weight gain

Key clinical trials

Pain Associated With Endometriosis (PHASE2)

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:

Danazol Twice Weekly CI brief — competitive landscape report
Danazol Twice Weekly updates RSS · CI watch RSS
Lumara Health, Inc. portfolio CI

Frequently asked questions about Danazol Twice Weekly

What is Danazol Twice Weekly?

Danazol Twice Weekly is a Synthetic androgen drug developed by Lumara Health, Inc., indicated for Hereditary angioedema (HAE), Endometriosis, Idiopathic thrombocytopenic purpura (ITP).

How does Danazol Twice Weekly work?

Danazol is a synthetic androgen that suppresses pituitary gonadotropins and has immunomodulatory effects, used to treat conditions involving abnormal bleeding or immune dysfunction.

What is Danazol Twice Weekly used for?

Danazol Twice Weekly is indicated for Hereditary angioedema (HAE), Endometriosis, Idiopathic thrombocytopenic purpura (ITP).

Who makes Danazol Twice Weekly?

Danazol Twice Weekly is developed by Lumara Health, Inc. (see full Lumara Health, Inc. pipeline at /company/lumara-health-inc).

What drug class is Danazol Twice Weekly in?

Danazol Twice Weekly belongs to the Synthetic androgen class. See all Synthetic androgen drugs at /class/synthetic-androgen.

What development phase is Danazol Twice Weekly in?

Danazol Twice Weekly is in Phase 2.

What are the side effects of Danazol Twice Weekly?

Common side effects of Danazol Twice Weekly include Virilization (acne, hirsutism, voice deepening), Menstrual irregularities, Hepatotoxicity, Lipid abnormalities, Weight gain.

What does Danazol Twice Weekly target?

Danazol Twice Weekly targets Androgen receptor; pituitary gonadotropin suppression and is a Synthetic androgen.

Drug class: All Synthetic androgen drugs
Target: All drugs targeting Androgen receptor; pituitary gonadotropin suppression
Manufacturer: Lumara Health, Inc. — full pipeline
Therapeutic area: All drugs in Hematology; Immunology; Gynecology
Indication: Drugs for Hereditary angioedema (HAE)
Indication: Drugs for Endometriosis
Indication: Drugs for Idiopathic thrombocytopenic purpura (ITP)

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