Research report

Research Tracker

What the FDA has approved, what developers report about products awaiting approval, and which studies the public registry lists as recruiting, for botulinum toxins, hair loss, migraine, dermatology, behavioral health, autism, and the ABA and OT therapies. Checked against primary sources on the date shown.

Last reviewed: October 28, 2026. We checked FDA label data, developer announcements and ClinicalTrials.gov on that date. Statuses can change afterward, so confirm with the FDA and the registry before relying on anything here.

Educational summary only. This is not medical advice and does not recommend any product. CMBH is not affiliated with these manufacturers. Treatment names are examples of what the FDA has approved, not recommendations.

At a glance

Botulinum toxins: the field in four points

Seven toxins are FDA approved

Counted by distinct active ingredient. Counted by brand label there are eight, because Botox and Botox Cosmetic have separate labels.

Two products were not approved

The FDA issued a Complete Response Letter for each, reported by the developers in April and July 2026. We found no later decision for either.

Approval is not availability

This page reports FDA approval status. It does not verify what is currently sold or stocked.

Registry listings are not approvals

The studies below are research. A listing does not show that a use is approved, safe or effective.

Approved today

FDA approved botulinum toxins

Indications as listed in FDA label data retrieved October 28, 2026. These are approved uses only. Doses, ages and safety information are in each full label.

Product	Generic name	Labeled indications	Source
Botox	onabotulinumtoxinA	Overactive bladder, urinary incontinence from detrusor overactivity, pediatric neurogenic detrusor overactivity, chronic migraine prevention, spasticity, cervical dystonia, severe underarm sweating, blepharospasm, strabismus	Label
Botox Cosmetic	onabotulinumtoxinA	Glabellar lines, lateral canthal lines, forehead lines and platysma bands, in adults	Label
Dysport	abobotulinumtoxinA	Cervical dystonia, glabellar lines and spasticity	Label
Xeomin	incobotulinumtoxinA	Chronic sialorrhea, upper limb spasticity, cervical dystonia, blepharospasm, and glabellar, forehead and lateral canthal lines	Label
Jeuveau	prabotulinumtoxinA-xvfs	Glabellar lines in adults	Label
Daxxify	daxibotulinumtoxinA-lanm	Glabellar lines and cervical dystonia, in adults	Label
Letybo	letibotulinumtoxinA-wlbg	Glabellar lines in adults (FDA approval letter dated 2024)	Label
Myobloc	rimabotulinumtoxinB	Cervical dystonia and chronic sialorrhea, in adults	Label

How we count: seven distinct active ingredients (onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA, prabotulinumtoxinA, daxibotulinumtoxinA, letibotulinumtoxinA, rimabotulinumtoxinB), eight brand labels. Presentations and vial sizes are not counted. Letybo's approval letter: FDA.

Not yet approved

Two products that received Complete Response Letters

What follows is how each developer described its FDA correspondence. The letters themselves are not public on this page.

Ready-to-use liquid toxin (relabotulinumtoxinA)

On July 1, 2026 the developer announced a Complete Response Letter. According to the developer, the letter cited observations from a pre-license inspection of its manufacturing site and analytical method optimization, and did not raise deficiencies in the safety and efficacy parts of the application. It said it plans to respond. Earlier, on February 2, 2026, it had announced FDA acceptance of a resubmitted application. As of October 28, 2026 we found no later FDA decision or resubmission announcement. Status: not approved in the United States. Developer announcement, July 1, 2026

Fast-acting serotype E toxin (trenibotulinumtoxinE)

On April 23, 2026 the developer announced a Complete Response Letter. According to the developer, the FDA requested additional information about manufacturing processes, the letter does not identify safety or efficacy concerns or request additional clinical studies, and it expects to submit a response. As of October 28, 2026 we found no later announcement of a resubmission, acceptance or approval. Status: not approved. Developer announcement, April 23, 2026

What a Complete Response Letter means

It tells a company that the FDA cannot approve an application as submitted. The company can respond and resubmit. It is not a final rejection.

Investigational uses

Approved uses and research are different

Any use not on a product's FDA label is investigational until the FDA approves it. The registry list below includes studies of products already on the market and of products not yet approved. A study listing says only that research is registered.

Hair loss

Approved treatments and what is pending

Two different conditions: pattern hair loss (androgenetic alopecia) and alopecia areata, an autoimmune condition. Indications from FDA label data retrieved October 28, 2026. Minoxidil was not rechecked individually.

Product	Generic name	Labeled indication	Source
Propecia	finasteride	Male pattern hair loss, in men only	Label
Minoxidil, topical	minoxidil	Sold over the counter for scalp hair regrowth in pattern hair loss. Details vary by product label.	Label
Olumiant	baricitinib	Severe alopecia areata. The label data we retrieved lists adults. The developer announced on September 25, 2026 an FDA approval for ages 12 and older.	Label
Litfulo	ritlecitinib	Severe alopecia areata in adults and adolescents 12 years and older	Label
Leqselvi	deuruxolitinib	Severe alopecia areata in adults	Label

Full labels list serious risks and who should not use each product. The Olumiant age expansion: developer announcement, September 25, 2026. The label we retrieved had not yet shown it, so confirm the current label.

Pending: topical clascoterone (male pattern hair loss)

On April 15, 2026 the developer announced positive 12 month Phase 3 results and said a U.S. FDA filing was planned for early 2027. We found no later filing. Status: not approved. Developer announcement, April 15, 2026

Migraine

Examples of approved treatments

Indications from FDA label data retrieved October 28, 2026 (Ubrelvy from its DailyMed label). This is not a complete list. Triptans, ergots, devices and other options are not shown. Botox for chronic migraine is in the botulinum toxin table above.

Product	Generic name	Labeled indication	Source
Ubrelvy	ubrogepant	Acute treatment of migraine with or without aura, in adults	Label
Nurtec ODT	rimegepant	Acute treatment of migraine and preventive treatment of episodic migraine, in adults	Label
Zavzpret	zavegepant, nasal	Acute treatment of migraine with or without aura, in adults	Label
Reyvow	lasmiditan	Acute treatment of migraine with or without aura, in adults	Label
Aimovig	erenumab	Preventive treatment of migraine, in adults	Label
Ajovy	fremanezumab	Preventive treatment of migraine in adults, and of episodic migraine in children 6 to 17 who weigh 45 kg or more	Label
Emgality	galcanezumab	Preventive treatment of migraine, and treatment of episodic cluster headache, in adults	Label
Vyepti	eptinezumab	Preventive treatment of migraine, in adults	Label
Qulipta	atogepant	Preventive treatment of migraine, in adults	Label

Pending decisions: we did not find a verified pending FDA decision on a new migraine product as of October 28, 2026. New research is in the registry list below.

Dermatology

Examples of approved treatments

Skin conditions people ask about most: eczema (atopic dermatitis), hidradenitis suppurativa and prurigo nodularis. Indications from FDA label data retrieved October 28, 2026. This is a short list of examples, not every approved treatment, and acne and psoriasis products are not shown. Pending decisions were not reviewed for this section.

Product	Generic name	Labeled indication	Source
Dupixent	dupilumab	Among its indications: moderate to severe atopic dermatitis in patients 6 months and older, and prurigo nodularis in adults. It has several non-skin indications.	Label
Adbry	tralokinumab	Moderate to severe atopic dermatitis in adults and in patients 12 and older	Label
Ebglyss	lebrikizumab	Moderate to severe atopic dermatitis in adults and in patients 12 and older who weigh at least 40 kg	Label
Bimzelx	bimekizumab	Among its indications: moderate to severe hidradenitis suppurativa and plaque psoriasis, in adults	Label

Full labels list serious risks and who should not use each product.

Behavioral health medicines

Examples of recently approved treatments

A short list of examples checked against FDA label data retrieved October 28, 2026. Behavioral health has many approved medicines, so this is not a complete list. Pending decisions were not reviewed for this section.

Product	Generic name	Labeled indication	Source
Cobenfy	xanomeline and trospium	Schizophrenia in adults	Label
Zurzuvae	zuranolone	Postpartum depression in adults	Label
Auvelity	dextromethorphan and bupropion	Major depressive disorder in adults, and agitation associated with dementia due to Alzheimer disease	Label

Autism medicines

What the FDA has approved, and what it has not

Two medicines carry an FDA indication for irritability that comes with autism. No medicine is approved to treat autism itself. Indications from FDA label data retrieved October 28, 2026.

Product	Generic name	Labeled indication	Source
Risperdal	risperidone	Among its indications: irritability associated with autistic disorder, in patients 5 to 17	Label
Abilify	aripiprazole	Among its indications: irritability associated with autistic disorder, in pediatric patients	Label

Leucovorin

Trade press reported that on about March 10, 2026 the FDA approved leucovorin for cerebral folate deficiency in people with a certain genetic variant, and not for autism. We did not retrieve the FDA label for this item. Trade press report, March 2026

ABA and OT

Therapies, not FDA products

Applied behavior analysis (ABA) and occupational therapy (OT) are therapies delivered by trained professionals. The FDA does not approve them as products, so there is no approval table here. Research on them is registered as studies, and the registry lists are below.

What to watch

Next decisions and updates

Whether each developer announces a resubmission, and what the FDA decides.
New or changed indications on current labels.
New study registrations and status changes on ClinicalTrials.gov.

Live registry

Studies the registry lists as recruiting

Studies from ClinicalTrials.gov that list a recruiting site in the United States, by area. Studies that have not started recruiting are not shown.

Botulinum toxins

Loading studies...

Hair loss

Loading studies...

Migraine

Loading studies...

Dermatology

Loading studies...

Behavioral health

Loading studies...

Autism

Loading studies...

ABA

Loading studies...

OT

Loading studies...

About these lists. These are third-party studies on the public registry. CMBH does not recruit for them, is not affiliated with them, and a listing does not mean CMBH can place anyone in a study. Open the registry record for eligibility and contact details.

Change log

What changed

October 28, 2026	Added dermatology, behavioral health medicine and autism medicine sections with registry lists. Products shown were checked against FDA label data retrieved that day, except the leucovorin item, which is from trade press.
October 28, 2026	Broadened the page to a Research Tracker and added hair loss, migraine, and ABA and OT sections. Approved products in the new tables were checked against FDA label data retrieved that day.
October 28, 2026	Reviewed all sections against FDA label data, developer announcements and the registry. Added the July 1, 2026 Complete Response Letter for the liquid toxin and corrected its status from under review. Added a definition of the count of approved products. Narrowed the registry list to recruiting studies.
October 28, 2026	Renamed from Neuromodulator Pipeline Tracker.
Earlier in October 2026	First version published.

Sources

Primary sources

Hear when studies open near you For investigators