Dated record · 13 entries · Last pass August 15, 2026
The HRT timeline, 2024 to 2027
Where things stand today
The class-wide boxed warning is off menopausal hormone therapy labels. The FDA announced removal in November 2025 and approved the revised labeling on the first six products on February 12, 2026. Twenty-nine drug companies submitted proposed labeling changes at the agency's request, and the FDA has published no schedule for the products beyond those six, so some still carry the old box.
The estradiol transdermal patch is in shortage on the ASHP list and has never appeared on the FDA's own shortage database. Both halves of that sentence are true at once and they are constantly reported as one fact. We re-ran the query against api.fda.gov on August 15, 2026 and estradiol still returns no matches, which keeps eased importation and wider compounding allowances off the table.
Below is how it got here, in order, with a source on every line. 2 of the 13 entries are checks we ran ourselves against a primary interface, reproducible from the URL on the row.
General information, not medical advice. Dates and sources are what this page is for; treatment decisions belong with a licensed clinician.
What happened, in order
- TreatmentsHappened
Veozah picks up a boxed warning for liver injury
The FDA added a boxed warning for hepatotoxicity to the fezolinetant (Veozah) label after liver injury was reported in the postmarketing setting. Veozah is one of two non-hormonal prescription drugs approved for moderate to severe menopausal hot flashes, so this warning sits on the main alternative to hormone therapy, in the year before the hormone therapy boxed warning came off.
Source: Veozah structured product label, openFDA. Veozah alternatives, label by label.
- RegulationHappened
The FDA expert panel on menopause and hormone therapy meets
Twelve named panelists, including WHI investigator JoAnn E. Manson, past Menopause Society president JoAnn V. Pinkerton, and Howard N. Hodis of USC, reviewed breast cancer, uterine cancer and cardiovascular risk against benefits to bone, genitourinary, cardiovascular and cognitive health, with specific attention to how the balance shifts with age at initiation, formulation and dose. This is the meeting routinely misdated to June 2026 in coverage of the label change.
Source: FDA Expert Panel on Menopause and Hormone Replacement Therapy for Women. The full black box chronology.
- RegulationHappened
The public comment docket closes
The FDA's public comment period on menopausal hormone therapy labeling closed at 11:59 p.m. ET. Six weeks later the agency moved.
Source: FDA Expert Panel on Menopause and Hormone Replacement Therapy for Women.
- RegulationHappened
The FDA announces removal of the boxed warning
The agency announced it was initiating removal of the class-wide boxed warning from systemic menopausal hormone therapy, the black-bordered box that had carried cardiovascular events, stroke, venous clots, breast cancer and probable dementia at the top of essentially every label regardless of the woman's age, the dose or the delivery route. Announcing removal is not the same as changing a label, which is why the next entry matters.
Source: HHS fact sheet on the boxed warning removal. What the warning actually said.
- SupplyHappened
ASHP starts listing estradiol transdermal systems in shortage
The American Society of Health-System Pharmacists added the estradiol transdermal system to its current shortages tracker. ASHP entries come from pharmacists, physicians, nurses and patients reporting what they cannot fill. The FDA, which designates a shortage only when supply fails a formal demand threshold, did not follow, and as of the last check on this page it still has not.
Source: ASHP drug shortage tracker, estradiol transdermal system (id 1206). The patch shortage, explained.
- RegulationHappened
The label changes are approved on the first six products
The FDA approved the revised labeling for six menopausal hormone therapy products, removing the cardiovascular disease, breast cancer and probable dementia statements from the boxed warning. Twenty-nine drug companies submitted proposed labeling changes at the agency's request, so the six are the beginning of the list rather than the whole of it. The endometrial cancer warning for unopposed estrogen stayed.
Source: FDA press announcement, labeling changes to menopausal hormone therapy products. What warnings remain.
- DemandHappened
Prescribing climbs to roughly one woman in twenty
Truveta's analysis of more than 130 million patient records put about 5% of women aged 45 to 54 on an estrogen-based HRT prescription by February 2026. Estrogen patch prescriptions were up 184% against 2018, including a 25.7% jump between July 2025 and February 2026. That window brackets the boxed warning announcement, which is the demand side of the supply story running alongside it.
Source: Truveta research, estrogen-based hormone replacement therapy.
- SupplyHappened
The shortage list passes a dozen brands and doses
NBC News reported that ASHP's estradiol transdermal listing had grown past a dozen brands and dosages, and quoted FDA Commissioner Marty Makary saying the boxed warning removal prompted a tremendous increase in demand but not enough to cause a shortage, calling it something to manage. The accurate reading is that the regulator has declined to designate a shortage while pharmacies and patients cannot fill prescriptions.
Source: NBC News, May 10, 2026. Which alternatives to ask about.
- SupplyHappened
All five US patch manufacturers report running at full capacity
CNBC reported that every American estradiol patch manufacturer was producing at full capacity and still could not meet demand, and described the squeeze as worldwide. A survey of roughly 8,000 women across 49 states found about half struggling to fill their estradiol patch, which turns a local stockout into a national access problem.
Source: CNBC, June 26, 2026.
- Our own checkHappenedWe checked this
We query the FDA's own shortage database and find no estradiol
We ran 4 separate searches against api.fda.gov, the FDA's official programmatic interface to its own drug shortage database, across four different field paths. Every one returned no matches, against 1,636 shortage records in the database that day. Two control queries returned live records for progesterone and bupivacaine, which is what makes the null result mean something rather than reading as a broken query. ashp.org returned a Cloudflare challenge to the same automated fetch that day, so we cite the ASHP half without claiming to have re-checked it.
Source: openFDA drug shortages API; openFDA shortages documentation. The full query log.
- SupplyHappened
Eight members of Congress write to the FDA
Representative Debbie Dingell (D-MI-06) and seven House colleagues pressed the administration to address estrogen patch shortages for menopause treatment, saying the shortage strains doctors' ability to treat menopause symptoms. A congressional letter carries no legal force. It does not add estradiol to the FDA shortage database, does not compel any manufacturer to produce more, and does not unlock eased importation or wider compounding allowances. It is the first dated federal marker on the record.
Source: Office of Congresswoman Debbie Dingell, press release, August 6, 2026. What the letter changes.
- TreatmentsHappened
Lynkuet's label records a seizure warning as a major change
Read from the elinzanetant structured product label via openFDA on August 11, 2026, with a label data timestamp of August 10. Lynkuet carries no boxed warning, and it does carry warnings for hepatic transaminase elevations, central nervous system depressant effects and daytime impairment, risk of pregnancy loss, and risk of seizure. The seizure entry is logged as a major label change in August 2026. Both approved non-hormonal drugs require baseline liver bloodwork before the first dose.
Source: Lynkuet structured product label, openFDA. Veozah against Lynkuet.
- Our own checkHappenedWe checked this
Re-check: the FDA still lists no estradiol shortage
We re-ran the same queries against api.fda.gov today. The database held 1,637 records. Searching the bare term estradiol and searching the substance name field both returned no matches, unchanged from the August 2 pass. One thing did change: the estrogen pharmacologic class query, which returned nothing two weeks ago, now returns exactly one record, a Fresenius Kabi fulvestrant injection posted August 14, 2026 with the status To Be Discontinued. Fulvestrant treats breast cancer and has nothing to do with menopause hormone therapy, so the estradiol patch position is unchanged. ASHP lists it. The FDA does not.
Source: openFDA shortages, estradiol query; openFDA shortages, estrogen class query. Live patch availability by provider.
What is on the calendar
Everything in this section is somebody else's published date or somebody else's published estimate, attributed to them and labelled as scheduled or expected. None of it has happened. We publish no forecasts of our own here, and a manufacturer recovery estimate on a pharmacist-reported list has moved before.
- SupplyExpected
Manufacturer recovery estimates for the high-volume patches
On the ASHP tracker, recovery estimates for several of the most-prescribed estradiol patches run into late 2026: Amneal's Dotti, Viatris's Lyllana and Noven's Vivelle-Dot. These are the manufacturers' own estimates on a pharmacist-reported list, they have moved before, and none of them is an FDA commitment. Treat a recovery date as the earliest plausible answer rather than a promise.
Source: ASHP drug shortage tracker, estradiol transdermal system (id 1206). What to ask a prescriber for now.
- RegulationExpected
Label changes on the products beyond the first six
Twenty-nine drug companies submitted proposed labeling changes at the FDA's request, and six products were approved on February 12, 2026. The agency has published no schedule for the rest. If your specific product still carries the old boxed warning, that is the reason, and it does not mean the class-wide review reached a different conclusion for it.
Source: FDA press announcement, labeling changes to menopausal hormone therapy products.
- TreatmentsScheduled
Estimated primary completion of the ABCL635 first-in-human study
NCT07118891 is a Phase 1/2 first-in-human study of ABCL635, a biological given by subcutaneous injection. All four primary outcomes are safety measures. Every hot-flash measure in it, including HFM-S, VMSM-S frequency and severity, and MENQOL, sits as a secondary outcome in Part C on a single dose. The trade coverage that describes this as a late-stage hot-flash result is describing something the registry record does not contain.
Source: ClinicalTrials.gov record for NCT07118891. What is actually in the pipeline.
How this record is kept
An entry goes in when a primary source carries the date: an FDA or HHS announcement, the openFDA API, the ClinicalTrials.gov registry, a congressional newsroom, a named manufacturer estimate on the ASHP tracker, or an outlet that names its own reporting date. Anything we cannot source stays out, including several widely circulated figures about the shortage and about the drug pipeline that we could not trace to a primary record.
One limitation worth stating. fda.gov, hhs.gov and ashp.org return 403 or 404 to automated fetches, so the rows citing those pages carry the agency URL without an automated re-check on the day of the last pass. That is why our own verification routes through api.fda.gov, which answers, and why the two rows marked as our own checks are the reproducible ones. A reader with a browser can open every link on this page.
Corrections go live the day they are confirmed. If a date here is wrong, or if the FDA adds estradiol to its database and this page has not caught up, tell us and it changes.
Go deeper
- The black box removal: what changed, what warnings remain
- The estrogen patch shortage and what to ask for instead
- Live patch availability, provider by provider
- The non-hormonal options, compared on their labels
- The HRT Price Index: what every platform charges
This is general information, not medical advice. A regulatory change to a label does not change what is right for one person. If the boxed warning removal or the patch shortage affects your prescription, that conversation belongs with a clinician. Compiled and reviewed by Iacob Pastina.
Midi Health
Sesame Care